Implantables Flashcards

(365 cards)

1
Q

What is the primary difference between active and passive bone conduction implants?

  • Passive devices require surgical placement of the transducer under the skin
  • Active devices have an implanted transducer that generates vibration directly to bone
  • Passive devices transmit sound via air conduction
  • Active devices depend on skin pressure to transmit sound
A
  • Active devices have an implanted transducer that generates vibration directly to bone

Active: implanted; implant generates vibration directly applied to the bone
Passive: Transducer is impeded in the speech processor. Sound processor generates stimulation that is applied from outside onto the skin. Less optimal; skin attenuates sound before it reaches the bone.

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2
Q

Which of the following is a fully implantable middle ear device?

  • SAMBA 2
  • Vibrant Soundbridge
  • MAXUM
  • Envoy Esteem
A

Envoy esteem

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3
Q

What is the primary benefit of bone anchored implants for individuals with single-sided deafness?

  • Reduction of the head shadow effect, improving speech recognition when sound comes from the poorer ear side
  • Enhanced ability to localize sounds using binaural cues
  • Improved hearing in noise due to bilateral input
  • All of the above
A

Reduction of the head shadow effect, improving speech recognition when sound comes from the poorer ear side

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4
Q

Which system uses a piezoelectric transducer for mechanical sound generation?
MED-EL BONEBRIDGE
Oticon Ponto
Cochlear Osia
Sophono Alpha 2

A

Cochlear Osia
* Envoy Esteem is also piezo

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5
Q

Which of the following is a true limitation of piezoelectric transducers in MEIs?

  • Limited output and narrow bandwidth make them unsuitable for moderate-severe HL
  • They require battery replacements every few days
  • They produce excess mechanical feedback
  • Output is dependent on the distance between the magnet and coil
A

Limited output and narrow bandwidth make them unsuitable for moderate-severe HL

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6
Q

Which of the following is not an indication for the Vibrant Soundbridge middle ear implant?

  • Normal middle ear anatomy
  • Sensorineural hearing loss
  • Word recognition scores of at least 50%
  • Age 12 years and older
A

Age 12 years and older
* MEI must be 18+

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7
Q

What makes electromechanical transducers more reliable than electromagnetic transducers?

  • They require no surgery
  • They do not require external power sources
  • They eliminate variability in magnet-coil distance
  • They have lower output and narrower bandwidth
A

They eliminate variability in magnet-coil distance
* they are housed together

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8
Q

Why do transcutaneous BCDs often have less efficient sound transmission compared to percutaneous systems?

  • The skin attenuates the vibratory signal
  • They use piezoelectric transducers
  • They are not fixed by osseointegration
  • They require higher powered batteries
A

The skin attenuates the vibratory signal

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9
Q

Which of the following statements about the Baha Connect system is TRUE?

  • It does not require osseointegration
  • It relies solely on adhesive pads for fixation
  • It is not MRI compatible
  • It uses a TiOblast™ surface to enhance osteoblast migration
A

It uses a TiOblast™ surface to enhance osteoblast migration
* type of osseointegration

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10
Q

The MED-EL Vibrant Soundbridge is FDA-approved for the treatment of conductive hearing loss.

True or False

A

FALSE
* CHL is a contraindiaction

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11
Q

In the Envoy Esteem middle ear implant system, which component is surgically coupled to the incus?
* Sensor
* Driver
* FMT
* Magnet

A

SENSOR
* The Esteem sensor is coupled to the body of the incus and contains a piezoelectric transducer that converts the movement of the incus into an electrical signal which is delivered via a lead to the Esteem sound processor.

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12
Q

Which of the following is a non-surgical bone conduction device?
Sophono
Cochlear Baha Attract
Oticon Ponto
MED-EL ADHEAR

A

MED-EL ADHEAR
* cochlear 5 Softband & soundarc

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13
Q

Which transducer type in MEIs has the disadvantage of output varying with distance?

A

Electromagnetic

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14
Q

How is the magnet in the MAXUM system activated to vibrate the ossicular chain?
By electromagnetic signals from an in-canal processor coil
By external piezoelectric transducer
By electrical impulses through the auditory nerve
By electrical signal generated by the external speech processor

A

By electromagnetic signals from an in-canal processor coil

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15
Q

What is the minimum age at which a child can be considered for surgical implantation of a percutaneous bone conduction hearing device?
3 years old
5 years old
8 years old
12 years old

A

5 years old

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16
Q

Which of the following is NOT an FDA-approved indication for the Envoy Esteem middle ear implant?
Unaided word recognition score of ≥40%
Moderate to severe sensorineural hearing loss
Conductive hearing loss without ossicular chain involvement
Minimum of 30 days of appropriately fit hearing aid use

A

Unaided word recognition score of ≥40%
* WRS must be good, 60% or better for MEI

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17
Q

In bone conduction implants, how is the process of osseointegration best defined?
* The biological adhesion of bone cells to the surface of a titanium implant, forming a stable and functional connection
* Surgical placement of a titanium screw into the mastoid bone
* The transmission of mechanical vibrations across the skin via a transcutaneous system
* The process of securing the abutment to the skull in a one-stage surgical procedure

A

The biological adhesion of bone cells to the surface of a titanium implant, forming a stable and functional connection

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18
Q

In implantable and non-surgical bone conduction devices, what is the name of the component that attaches the sound processor to an abutment, magnet, or softband?

Snap coupling
Floating mass transducer
Magnet
Sensor

A

Snap coupling

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19
Q

What tests needs to be done to be able to recommend ME implantable devices to patients

A
  • Air and bone conduction pure-tone audiometry at octave and inter-octave frequencies from 250 to 8000 Hz.
  • No air bone gap of more than 10 dB
  • Evaluation of middle ear function through measures (tymps, ARTs, wideband reflectance)
  • A trial with hearing aids.
  • REM Verify Optimal HA’s .
  • Aided word recognition assessment at speech levels consistent with speech levels encountered in daily listening situations (60 dB SPL)
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20
Q

According to FDA guidelines, which type and degree of hearing loss typically qualifies a patient for a middle ear implant?
* Moderate to moderately severe sensorineural hearing loss
* Mild to moderately severe sensorineural hearing loss
* Moderate to profound sensorineural hearing loss
* Any degree or type of hearing loss

A

Moderate to moderately severe sensorineural hearing loss

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21
Q

The sensor and driver on the Esteem middle ear implant are examples of piezoelectric transducers.
True or False

A

TRUE

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22
Q

What are the FDA-approved indications for middle ear implants

A
  • 18 years & older w/ SNHL.
  • Moderate to moderately severe SNHL w/ WRS greater than >60% correct.
  • HL Stable
  • Normal middle ear anatomy and function without an infection.
  • Prior experience with hearing aids.
  • Off-label recommendations for middle ear implants may be made when medically justified, regardless of FDA-approved indications.

IMPORTANT TO KNOW

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23
Q

What does it mean if at middle ear implant patient has a WRS score of less than 60%?

A
  • Individuals with WRS <60% correct in optimal conditions may not experience significant improvement in hearing performance with a middle ear implant.
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24
Q

how is candidacy assessed for middle ear implant?

A

Preop Assessment
* Air and bone conduction pure-tone @ 250 hz - 8,000hz (octave and inter-octave frequencies) ( no ABG more than 10db)
* Check middle ear function w/ tymps, ARTs, wideband reflectance
* HA’s trial (conventional air-conduction hearing aids).
* REM measurements to ensure optimal hearing aid output. (during trial or to make sure use of was optimal)
* Aided WRS at speech levels of daily listening (60 dB SPL)
* Medical evaluation by an otologist & CT check ME anatomy & surgical planning
* MRI to assess the central nervous system.

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25
What are the theoretical advantages of middle ear implants, and which of these remain applicable today? ( true today)
**Greater Gain:** increased gain prior to acoustic feedback. but feedback risk remains due to enhanced mechanical oscillation. **Avoidance of the Occlusion Effect**: crucial for individuals with external otitis or skin allergies. unaffected by cerumen-related problems. **Improved Comfort:** especially with fully implanted **Higher-Fidelity Sound:** higher-fidelity sound w/less distortion. ***Aesthetic Appeal:*** especially if components are implanted under the skin. (today) ***Continuous Wear:*** Fully implantable allow 24/7 wear, including showering and sleeping, with minimal acoustic feedback risk. (today)
26
What are the theoretical disadvantages of middle ear implants?
* **Surgical Procedure:** Requires 1-2 hours under general anesthesia, w/ facial nerve injury and infection risk. Complication rates are generally low, but healing time is needed before activation. * **Cost and Insurance:** Higher costs, not typically covered by insurance. PT's out-of-pocket expenses for AuD services. * **Hearing Implications:** Some MEI involve disarticulation of ossicular chain, resulting in maximum conductive hearing loss when inactive. * **Not MRI Compatibile**: Most MEI contain magnets, prohibiting MRI without implant removal. ***Exception***: MED-EL VIBRANT SOUNDBRIDGE allows MRI up to 1.5-tesla without removal. * **Verification Challenges:** REM unfeasible for verifying gain/output settings. b/c MEI don't produce acoustic output in the ear canal, making traditional
27
What MEI is MRI compatible and up to what TESLA?
**MED-EL VIBRANT SOUNDBRIDGE** allows MRI up to **1.5-tesla** without removal.
28
What are the three types of transducers used in middle ear implants?
Piezoelectric Electromagnetic Electromechanical
29
Crystals Ocillate when electicity is applied and ossiclation enegerate electrical volatge, convereted to mechanical energy, when attech to ME moves ossicles converting Mechnical Energy to electrical signal for processing
Piezoelectric
30
Pros and Cons of the Piezoelectric transducers
Pros * **No external power needed** * **strong stability and durable**. Cons * not enough amplification formoderate to severe hearing loss due to their **limited output and narrow bandwidth**
31
A magnet is attached to the ossicles. A wired coil is placed nearby. When electrical current flows through coil it creates a changing magnetic field. This MF causes the magnet to vibrate (oscillate back & forth). Magnet Oscillation sends mechanical energy to ossicaular chain. * Magnet movement Intensity and frequency is equal to the electrical current's characteristics.
Electromagnetic
32
Pros and cons of the Electromagnetic transducer
Pros: None? Cons: * output is dependent on the magnet to coil distance * increased distance = decreased output.
33
A magnet & coil is attached to the ossicles (housed together). When electrical current flows through coil it creates a changing magnetic field. This Magnetic Field causes the magnet to vibrate (oscillate back & forth). Magnet Oscillation sends mechanical energy to ossicular chain.
Electromechanical
34
Pros and Cons of the Electromechanical transducer.
Pros: * highest output and widest frequency responses * Not affected by variable output due to changes in magnet to coil distance. (housed together) Cons: * More complex design and more prone to mechanical failure. Small drawback now with modern tech
35
What middle ear implant devices are currently available?
Partially Implantable * Vibrant Soundbridge * MAXUM Fully Implantable * Envoy Esteem
36
Label 1-4 on the Vibrant Soundbridge
1. A receiving coil that surrounds a biocompatible magnet 2. An internal processor and stimulator (i.e., the “demodulator”) 3. A lead (the Conductor Link) that delivers electrical current from the stimulator to the transducer 4. Floating Mass Transducer (FMT)
37
Vibrant Soundbridge * implant type * Basic components * Transducer type * How does it work
MED-EL Vibrant Soundbridge * **Partially implantable MEI** * Two basic: **External sound processor** (SAMBA 2 audio processor & the MED-EL Vibrant Soundbridge **Implant** * **Electromagnetic Transducer** * Microphone capures sound --> analyzed by digital signal processor--> converted to electrical --> transmitted via electromagnetic to--> processor transmitting coil --> coil recieves and converts to electrical signal --> to implant processor for analysis --> eletrical current down the conductor link --> to FMT (electromechanical) --> coil creats mag field and magnet ossilate wi/FNT
38
MED-EL VIBRANT SOUNDBRIDGE contain what 2 basic componens?
Partially Implantable MEI * An external sound processor known as SAMBA 2 audio processor * The MED-EL VIBRANT SOUNDBRIDGE implant
39
The FMT on the MED-EL vibrant soundbridge is coupled to what?
FMT coupled to the **long process of the incus** * rarely couple to the incus body * for mixed/condutive HL - coupled to round window
40
How does the MED-EL VIBRANT SOUNDBRIDGE work? | Not that important for comps
* Sound is pick up by the microphones on the sound Processor and analyzed by the digital signal processor * Signal is converted to electrical current and transmitted though the processor transmitted coil * coil recives and converts to electrical signal & delivered to implant * Analysised by implant * travels down conductor link lead to FMT * FMT is magnet and col to create magnetic field (electromagnetic) Sound picked up --> analyzed --> converted to electric --> transmitted through coil--> coil converts to electrocal signal--> delivers to implant ---> analysied --> travel down conductor link lead --.> to FMT--> | Not that important
41
Vibrant sondbridge contraindications
* CHL * Retrocohlear or Cental Auditory disorder * Tympanic membrane perforation associated w/ME infection * A skin or scalp condition | MEI
42
The MAXUM contain what two components?
An externaly worn Ear Level Sound Processor aka Integrated Processor & Coil (IPC). made up of.. * Micorphone * Digital SIgnal Processor * Eletroomagnetic coil Magnet (house in titanium) * attached to ossicles
43
How does the MAXUM work?
* IPC (Integrated Processor & Coil) houses both sound processor & eletromagtic coil * IPC receives sound, amplifies it and convert to electrical current * delivered to electromagnetic coil * as E current travel throough coil it's converted to electromagnetic signal * EM signal moves across the TM and towards MAXUM Magnet * Magnet coupled to neck of stapes * engages in electromagtic virbations and process
44
MAXUM FDA Contraindications
* CHL * Retrocohlear or CAPD * Active Middle ear infections * TM perfs w/recurrent ME infection * Disabling tinnitus
45
what device is the only FDA-approved fully implantable hearing device?
Envoy Esteem
46
what type of transducer is the envoy esteem?
Pizeoeletric
47
the envoy esteem is made of up what 4 components and where is it implanted?
Implated in the **temporal bone** 1. Sensor 2. Sound Processor 3. Driver 4. Non-rechargeable lithium - iodide battery
48
What is a Middle ear implant?
A surgically implanted component that is coupled to a structure in the middle ear and that mechanically oscillates to facilitate stimulation of the cochlea.
49
Electromagnetic Transducer for BAHA * parts and process
* armature (moves) & the yoke (fixed) w/small air spaces between them * Armature is surrounded by wired coils and contains a permanent magnet (yoke remains fixed and does not move) * electrical current is delivered though the coil creating a magnetic field in the amature * fluctuations of field = oscillating magnetic field * creating attract and repel between the armuture and yoke * creating mehcnical energy that is transmistted to the skull when sound processor is coupled to the head.
50
What are the Basic Components of the BAHA?
**External sound processor** * captures acoutics signals, converst to mechnical vibration and delivers the M vibrations to the internal component **Titanium components** * surgically implanted in the skull and used to deliver mechnical vibrations to the cochlea via bone conduction
51
What are the common complications associated with BAHA?
* Peri-implant infection * Flap Necrosis * Loss of the abutment (infection or trauma) * Osseointegration failure * Skin Numbness * Skin overgrowth over the abutment
52
osseointegrated vs. non-osseointegrated
**Osseointegrated:** implants require surgically placing an implant screw that integrates with the temporal bone. (bone adheres to screw) **Non-osseointegrated:** implants are attached to the bone of the skull, but do not rely on osseointegration for the function of the device
53
direct drive vs. skin drive
Skin Drive: Vibrations are transmitted to the bone through the skin via an external drive placed on the skin surface Direct Drive: Vibrations are directly transmitted to the bone through an implanted transducer without the need for skin transmission
54
Percutaneous VS Transcutaneous
**Percutaneous**: Penetrating the skin; this is what people refer to as Baha **Transcutaneous:** Across the skin. vibrations from the soound processor are transmitted across the skin. * keeps skin intect.
55
active vs. passive implant
Active: Implanted; implant generate vibrations that is directly applied to the bone. (direct drive bone condution). * Optimal BC sound transmission Passive: Transducer is imbeded in the speech processor. Sound processor generates stimultion that is applied from the outside onto the skin. * less optimal, Skin attenuates sound
56
Implantable BCHs are available in what two basic forms?
Percutaneous systems & Transcutaneous systems
57
The FDA-approved indication for activation of BC. Percurtaneous
* 5 yrs + & 2.5 mm skull thickness * CHL & no benefit from HA's * Mixed HL Mild to Moderate SNHL w/BC thrsholds of 65db or better * for SSD Better ear BC thresholds 20db HL or better (but these imlants are generally able to provide enough stimultion that will allow transfer of the BC signal to the better hearing ear w/mild HL
58
what is skin drive & an example
Skin drive: vibrations are transmitted to the bone through the skin via an external device placed on the skin surface * headband * Softband * adjoin * **Baha attract** * **Sophono**
59
What is direct drive and an example
Direct drive: vibrations are directly transmitted to the bone through an implanted transducer without the need for skin transmission * Baha * Ponto * BoneBridge * BCI
60
Osseointegration and an example
* process in which bone cells attach/adhere to the surface of a metal (titanium) surface. * implants require surgically placing an implant screw that integrates with the temporal bone. * BAHA * BAHA attract * Osia * Ponto
61
Non-osseointegration and an example
implants are attached to the bone of the skull, but do not rely on osseointegration for the function of the device. * Bonebridge * Sophono
62
What is Passive and an example
Passive: transducer is imbeded in the speech processor. stimultion is applied outside onto the skin. Less optimal * BAHA * Baha Attract * Sophono * Headband * Softband
63
What is Active and an example?
Active: transducer implanted, directly to the bone. Optimal tranmission * Bonebridge * BCI
64
What is Percutaneous and an example.
Penetrating the skin; this is what people refer to as Baha. * Baha * Ponto
65
Transcutaneous and an example
Across the skin. The vibrations from the sound processor are transmitted across the skin. Keeps the skin intact. * Baha Attrect * Sophono * Headband * Softband * Bonebridge (trans & active) * BCI (trans & active)
66
Osseointegration refers to the process in which what?
Osseointegration refers to the process in which **bone cells attach/adhere to the surface of a metal (titanium) surface.**
67
The FDA-approved indication for activation of BC Transcutaneous
* 5 yrs + w/ 2.5mm skull thickness & at least 3mm skin thickness. * BC thresholds of 45dbHL ot better * Best for CHL or SSD w/ normal BC thresholds in better ear (due to any attenuation casued by the skin
68
Stages of osseointegration
A screw is surgically placed and eventually, osseointegrate to the temporal bone; bone cells attach/adhere forming a *biologic attachment*. * **One stage:** implant with the abutment is placed as a single piece in one surgical setting * **Two stages:** the fixture is implanted in the first stage and the abutment is placed after osseointegration has taken place which is usually 3–6 months
69
Advantages of Transcutaneous
* Lower rate of complications at and around incision site * Minimal wound care * Better aesthetics; invisable * Less risk of trauma to implant * Can be activated wi/ 4 weeks of surgery
70
Advantages of percutaneous
* Optimal Signal Delivery * Better for PT's w/ sensitive skin * Excellent retention for active recipients * Approved for MRI w/strength up to 3T * artifact/shadow minimized
71
Limitations of percutaneous devices
* higher risk of abutment - related complications (skin overgrowth, infections and granulation tissue) * high risk of loss or truma * high hygiene maintain * 3 to 6 mos waiting btwn surgery and coupling of processor to abutment (allow for osseointegration) * Astheic concerns * Issues w/ attching soound processor when dexterity is a cocern
72
Limitations of transcutaneous devices
* Skin attenutaion up to 20db * insufficient power for BC mild to moderate HL * not MRI cleared above 1.5 T * magnetic plate create artifact and shadowing around the implant area * magnet pressure could aggreavate soft tissue problems
73
What detemines candidacy for Bone conduction devices?
* AC threshfrom 250 - 8k * BC Thresholds 250,500,1,1.5,2,3,4 (mask when possible) * WRS (CNC & Az-Bio)
74
Bone Conduction Candidacy Criteria CHL/MHL
* Average BC thresholds @500,1,2 & 3 khz candidate if **≤ 65 dB HL** (65 dB HL or better) * Average ABG @500,1,2 & 4khz Candidate if **≥ 30 dB** (ABG is 30 dB or greater) * 5 yrs + (surgical) * Any age (Non-surgical)
75
Bone Conduction Candidacy Criteria SSD
* Poor ear: Profound SNHL **≥ 80 dB HL** (80 dB HL or worse) * Good Ear: AC PTA (500,1,2,3) **≤ 20 dB** (20 dB HL or better) * 5+ (surgical) * any age (non surgical)
76
What are the main benefits of using a bone conduction device for patients with SSD?
BCD alleviates the head shadow effect **improving speech recognition** in quiet and in noise when speech arrives from the side of the poorer ear.
77
What are the main benefits of using a bone conduction device for patients with unilateral CHL?
efficacy remains **uncertain** with variability in outcomes across studies.
78
What are the main benefits of using a bone conduction device for patients with Bilateral CHL?
Significant improvement in audibility, speech recognition in quiet and in noise, and localization.
79
What are the main benefits of using a bone conduction device for patients with candidates w/ mild BC thresholds?
mild BC thresholds typically experience significant **audibility improvements**, while those with poorer thresholds may not benefit as much from BCDs.
80
What is the protocol and test setup for aided speech assessment in patients with CHL/MHL for a Bone conduction device
* **Functional Gain SF**, Warble tone detection thresholds (500 -6khz) * **Unaided & aided CNC** @65 *dbSPL* speaker 0 azimuth, 1 meter away * Adaptive speech in noise, Aided & unaided. (**QuickSIN**, BKB-SIN) 65dbA signal routed to a speaker 0 and 1 meter away & noise 90 or 180 behind PT * Compare performance between **aided and unaided**
81
What is the protocol and test setup for aided speech assessment in patients with SSD fro bone conduction device?
* **Functional gain SF**, Warble tone (500-6khz) * Adaptive Speech in noise aided & unaided **@65dbA** (**quickSIN**,BKB-SIN) * 90 and -90 (270) azimuth * Signal to poorer ear and noise to better ear * Improved SNR between aided and unaided = BCD benefit | (no CNC unlike CHL)
82
What are the current bone conduction devices?
Cochlear Baha * **Baha Connect** * **Baha Attract** * **Osia** Otocon * **Ponto** MED-EL * **Bonebridge** * **ADHEAR** Medtronic * **Sophono** Non-surgical * **Baha 5 Softband** * **SoundArc**
83
what are the Four major manufacturers of implantable bone conduction devices.
Cochlear Baha Oticon Ponto MED-EL BONEBRIDGE Medtronic Sophono
84
What are the two types of Cochlear baha & there implant types
**Baha Connect** * Osseointergated * Percutaneous * Direct Drive * Passive **Baha Attract** * Osseointegrated * Transcutaneous * Skin Drive * Passive
85
Baha Connect * Osseo or non-osseo * percutaneous or transcutaneous, * passive or active * Direct or skin drive * function * info
* Osseointegrated (tioblast) * Percutaneous * Passive * Direct Drive * FDA 12 week gap btwn implantation & connection * activation wi/4-6 wks * MRI compatabile 3T
86
Baha Attract * Osseo or non-osseo * percutaneous or transcutaneous, * passive or active * Direct or skin drive * function * info
* Osseointegrated * Transcutaneous * Passive * Sjkin Drive * 4 wks should pass btwn implantation and * MRI 1.5 T
87
Key benefit of the Osia?
* no movement between parts that wear down over time * excellent hearing performace * slim, smart and robust * powerful and consistent performace
88
MED- EL Bonebridge * Osseo or non-osseo * percutaneous or transcutaneous, * passive or active * Direct or skin drive * info
* Non-Osseointegrated * Transcutaneous (completely under the skin) * Active * Direct drive * wireless signal transmission between the SAMBA 2 audio processor and the active implant.
89
Medtronic Sophono * Osseo or non-osseo * percutaneous or transcutaneous, * passive or active * Direct or skin drive * info
* non-osseointegrated * Transcutaneous * Passive * Skin drive * 45 minute surgery * MRI 3 T
90
MED-EL Adhear
* Non - surgical * Stick, click, hear * Skin drive * passive * Contains an adhesive adapter placed behind the ear coupled to the sound processor and delivers mechanical oscillations to mastoid bone
91
What nonsurgical bone conduction options are available to patients?
* ADHEAR * Baha Softband & Sound Arc
92
What is a cochlear implant?
A cochlear implant is a device surgically inserted into the ear to help people with severe HL it works by directly stimulting the auditory nerve using electrical signals, bypassing the damaged parts of the inner ear.
93
What part of the inner ear is damaged and how does a CI bypass that system?
The hair cells are damaged. CI bypass this by directly stimulting the auditory nerve with electrodes. The electrodes are inserted into the cochlea. They send electrical impulses that stimulate the auditory nerve fibers indirectly, through the cochlear structures. and
94
What are the three major manufactures of CI?
Cochlear Nucleus Advanced Biontics MED-EL
95
What is the difference between “labeled” and “off-label” indications?
**Labeled:** Manufacturer-defined indications listed in the physician's package insert. **Off-labeled:** Provision of a CI to a patient who does *not* meet the approved indications is often referred to as “off-label” use.
96
when would “labeled” and “off-label” indications each be considered?
Labeled: when Patient meets the criteria for CI Off -labled: SSD for example in AB - only have label for bilateral
97
if a clinican recommends off-label usage what are the three conditions that must be met?
* Well informed about the product. * Base its use on firm scientific rationale and on sound medical evidence. * Maintain records of the product's use and effects.
98
What are the FDA approved indications for traditional CI candidacy for Cochlear
(9-24 Months) * Profound SNHL in both ears Children (2-17 Years) * Severe to profound SNHL in both ears 18 yrs + * Moderate-profound SNHL, bilaterally. * CNC 60% or less → AzBio Score of 60% or less.
99
What are the candidacy criteria for children
**9 - 24 mos:** Profound bilateral SNHL >90db HL at 1,00hz **2 - 17 yrs:** bilateral severe to profound SNHL * Limited benfit from binaural HA's * Lack of progress in development auditory skills with HA's & aural rehab for 3 to 6 mos * 3-6 mos HA trial
100
What are the candidacy criteria for SSD - CI
* 5 years+ * Normal or nearly normal hearing sensitivity in the better ear; severe to profound SNHL in the poorer ear * Score of 5% or less using CNC; additional recommendations based on MSTB3 you could AzBio 0 SNR.
101
What are the candidacy criteria for AHL - CI
AHL * 5 years+ * Thresholds 90 dB HL or greater in the ear to be implanted and mild to moderately severe SNHL in the better with a difference of 15 dB HL or more between ears. * Score of 5% or less using CNC; additional recommendations based on MSTB3 you could AzBio 0 SNR.
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What are the candidacy criteria for EAS/Hybrid - CI
EAS/Hybrid * 18 years+ * Thresholds of 60 dB HL or better through 500 Hz and 70 or worse for 2000 Hz+ * A score of 60% or less using CNC → a score of 60% or less using AzBio at 10 dB SNR
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SSD is defined as what
SSD is defined as **profound sensorineural hearing loss in one ear** and normal hearing or mild sensorineural hearing loss in the other ear.
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AHL is defined as what?
AHL is defined as **profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss in the other ear**, with a difference of at least 15 dB inPTAs.
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What are the current Medicare eligibility criteria for cochlear implant coverage?
* bilateral moderate-to-profound SNHL with limited benefit from appropriate HAs. ≤60% correct scores in the best-aided listening condition on open-set sentence cognition tests. * No ME infection, normal inner ear and auditory nerve. * No contraindications to surgery. * The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling.
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Under what circumstances would the hearing aid trial period be waived for children?
If the child has been diagnosed with Meningitis, they will implant before ossification.
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What is the minimum and maximum age approved by the FDA for cochlear implantation?
Min: 9 months Max: none, if they if they meet the criteria
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Why is it important to image the auditory anatomy with CT and/or MRI prior to implantation?
Imaging of the cochlea anatomy with CT or MRI to determine: * If it is **possible to insert an electrode array** * Confirm that the **auditory nerve is present and/or normal** * Which **ear** may be **most suitable**
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What are some absolute (not relative) contraindications for cochlear implantation?
Anatomic * Absent cochlea or cochlear nerve * Neurological damage impeding aud processing * Damaged auditory cortex Medical * Medical conditions preventing surgery * Medical risks of surgery outweight benefits Not a CI candidate * a child who has signifant residual hearing & good HA benefit * Absence of CN 8 * Absence of the labyrinth * 20 + w/prelingual HL * cognitive impairments that would prevent rehab * active external or middle ear infection * allergy ot intolerance to device materials
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what are the factors known to affect cochlear implant outcomes & how
* Duration of deafness Longer = worse outcomes * Age of implantation Younger = better outcomes * Motivation & support Higher = better outcomes * Mode of communication Listening and spoken language support better outcomes * Etiology Some causes predict better outcomes (e.g., genetic, Meniere’s) * socioeconomic status Higher SES = better outcomes * Preoperative residual hearing Some hearing = better outcomes
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What are the 60/60 guidelines?
60/60 guideline **referal for CI eval criteria** PT's should be referred if * in their better ear they score **60%** or worse on **WRS** unaided * **PTA** in the better ear is **60dbHL** or worse unaided
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How do the 60/60 guidelines help to address the under-referral of cochlea implant candidates?
Before 60/60 audiologists we're not referring patients that needed to be referred due to the fact that they didn’t know the qualification criteria for referral.
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Required procedures prior to conducting a candidacy assessment? | Broad
* Comprehensive Audiological Evaluation * Hearing Aid Verification * Aided Speech Recognition Testing * Outcome Measures
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Why is it important to include 125 Hz when evaluating CI candidacy?
* to **assess hearing preservation** and **guide post - op** amplification strategy * to **support counseling** by setting expectation about potential HL
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According to MSTB-3, what are the four key steps in the cochlear implant candidacy assessment process recommended for best clinical practice?
* Comprehensive Audiological Evaluation * Hearing Aid Verification * Aided Speech Recognition Testing * Outcome Measures
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what is the first key step in the MSTB-3 process and what is involved?
Comprehensive Audiological Evaluation * Otoscopy * Acoustic Immittance * Air conduction * 125 - 8,000hz w/inserts
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what is the second key step in the MSTB-3 process and what is involved?
Hearing Aid Verification * Choose and fit HA's to optimize WRS performance * Listening check and or electroacoustic test for internal noise or distortion * REM to verify output matches targets * Verify output with a calibrated speech signal at 60/65 dbSPL
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what is the third key step in the MSTB-3 process and what is involved?
Aided Speech Recognition Testing * Speech discrimination score are key for candidacy * Calibrate - very important * Aided Speech recohnition is evaluted w/ the minimum speech test battery (MSTB) * CNC & AzBio (RE only,LE only & bilateral if needed)
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what is the fourth key step in the MSTB-3 process and what is involved?
Outcome measures * Patient reported outcome measures. * Questionnaires.
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What is the purpose of a hearing aid evaluation prior to beginning aided speech assessment?
* Hearing aids should be fit appropriately to maximize aided speech performance.
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What is the purpose of calibration prior to aided speech assessment?
Calibration ensures **speech stimuli are presented at consistent, clinically relevant levels**. * Enables reliable tracking of PT's Progress * Outcome measures remain valid & compariable * inaccurate calibration = inappropriate CI referrals (under or over qualified)
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Free-field calibration of speech stimuli requires what?
SF calibration uses speech simuli Input calibration & Output Calibration
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For free field calibration what does input calibration do?
Input calibration – **prevents distortion or clipping of the input signal**
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For free field calibration what does output calibration do?
Output calibration – **ensures that speech materials are presented in the SF at the intended level**
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Behavioral measuremnts after implantation are used to what?
* program the CI * Monitor the developemnt of speech perception * provide an indication of auditoy function or how child is usng CI to hear
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what is involoved in the behavioral assessment for the post opertive protocol?
MSTB-3 provides a structured protocol for postoperative testing * **Unaided** audiometric thresholds (125 to 8000 Hz) in the **implanted ear**; this includes AC & BC * **Unaided** thresholds for the **non-implanted** ear (for bimodal listeners) * **Aided soundfield** thresholds for the implanted ear(s) * **Aided speech assessment** * Speech Recognition Testing CNC and AzBio tests under aided conditions * May include comparison between CI alone and CI + HA (for bimodal benefit)
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what is involoved in the subjective assessment for the post opertive protocol?
Questionaires to evalute percived benfit and/or quality of life * CIQOL-10, SSQ-12, THI, GAD-7, PHQ-9 (as needed) * Assess QOL, communication, mental health, and patient perception
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What is the recommended MSTB-3 follow-up schedule after implantation, and when should additional visits be considered within that timeline?
Postoperative testing at **3 months & 12 months** following implantation for all patients * If performance is **suboptimal at 3 mos** consider additional testing before 12 mos
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What are the main speech tests used in the MSTB-3 battery?
**CNC** & AzBio
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What approaches are used to isolate the non-test ear (NTE)?
* **Plug and muff** approach, ideal for patients who struggle to process signal from masking noise. * **Masking noise** delivered via insert earphones to the better ear. * **Insert earphone + circumaural headphones**; combines acoustic sealing with masking for enhanced isolation
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How is ANSD diagnosed in children?
Normal OAE & Abnormal ABR
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Why is determining the site of lesion important?
ANSD involves disrupted neural synchrony, often at the inner hair cells, auditory nerve, or brainstem. Identifying the site of lesion is critical to: * Predict CI outcomes * Guide appropriate intervention strategies * Rule out non-cochlear causes that may not benefit from implantation The presence of ANSD may influence CI candidacy decisions and postoperative expectations
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What are the External components of a CI?
* Microphone * Digital Speech Processor * Cord, Coil/antenna * Magnet * Power source
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What are the Internal components of a CI ?
Magnet Receiving/transmitting coil Digital signal processor: Stimulator for electric pulse generation Electrode leads Electrode array
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What are the *Internal* components of a CI and the function of each?
* **Magnet**: Maintain connectivity with external hardware * **Receiving/transmitting coil:** Receives data delivered by external transmitter via radio frequency * **Digital signal processor:** Receives signals from the speech processor and converts them into electric impulses. * **Stimulator for electric pulse generation:** Decodes, analyzes, and delivers data to electrode array * **Electrode leads:** Deliver the electric current from the stimulator to the electrode array that is housed within the cochlea. * **Electrode array:**Stimulate the auditory nerve fibers in the cochlea
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Identify Image
1. **Microphone** 2. **Speech Processor** 3. **Cord** 4. **External transmitter** 5. **Magnet** 6. **Power source**
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What are the *External* components of a CI and the function of each?
1. **Microphone** picks up the acoustical signal and converts it to an electrical signal for input to the speech processor. 2. **Speech Processor** converts a microphone input into electrical stimulation. 3. **Cord** for delivery of electrical data. 4. **External transmitter** to deliver data to the internal receiver (antenna) via radio frequency. 5. **Magnet** to locate and maintain connectivity between internal and external components. 6. **Power source**: Rechargeable or disposable batteries
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In general, how does a cochlear implant convert sound into electrical stimulation, step-by-step, from sound pickup to nerve stimulation?
* A microphone picks up sound from the environment, amplifies it, and converts it into an electrical signal. * The electrical signal is transmitted to the speech processor. The amplitude, duration, and rate of these pulses are controlled by the speech processor. * The speech processor analyzes incoming speech and converts it into digital information * The speech processor sends this digital information to the external transmitting coil. * The external coil transmits both power and digital information through a RF link to the internal receiver/stimulator. * The receiver decodes the digital signal and delivers electrical stimulation pulses to the electrode array implanted inside the cochlea. * The electrodes stimulate the auditory nerve terminals using a series of biphasic current pulses.
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Traditional CI indications
(9-24 Months) * Profound SNHL in both ears Children (2-17 Years) * Severe to profound SNHL in both ears 18 yrs + * Moderate-profound SNHL, bilaterally. * CNC 60% or less → AzBio Score of 60% or less.
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EAS/Hybrid CI Indications
* 18 years+ * Thresholds of 60 dB HL or better through 500 Hz and 70 or worse for 2000+ Hz * SNHL - No ABG greater than 15db * A score of 60% or less using CNC → a score of 60% or less using AzBio at 10 dB SNR
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SSD CI Indications
* **5 years+** * Better ear: Normal or nearly normal hearing sensitivity in the better ear * Poor Ear: **severe to profound SNHL** * **5% or less using CNC**; additional recommendations based on MSTB3 you could AzBio 0 SNR.
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AHL CI Indications
* 5 years+ * Poor Ear: profound SNHL * Better Ear: mild to moderately severe SNHL * Difference of 15 db between ears Thresholds 90 dB HL or greater in the ear to be implanted and mild to moderately severe SNHL in the better with a difference of 15 dB HL or more between ears.
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List the CMS criteria for Medicare coverage of CIs in adults
* Diagnosis of **bilateral moderate-to-profound SNHL** with limited benefit from appropriate HAs. * **≤60% (or less)** correct scores in the best-aided listening condition on open-set sentence cognition tests. (CNC & AzBio) * **No ME infection, normal inner ear and auditory nerve.** * No contraindications to surgery.
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Absolute contraindications for cochlear implantation
Anatomic * Absent cochlea/cochlear nerve * Neurological damage impeding auditory processing * Damaged auditory cortex Medical * Medical condition(s) preventing surgery * Medical risks of surgery exceed expected benefits Not a CI candidate * A child w/significant residual hearing levels and receives good benefit from HAs * Absence of the VIIIth cranial nerve * Absence of the labyrinth (Michel’s Aplasia) * > 20 yrs patient with prelingual deafness who has never acquired speech * Cognitive impairment that would prevent adequate rehabilitation (dementia) * Lack of adequate support to ensure attendance at activation and programming sessions * Active external or middle ear infections * Known allergy and/or intolerance of device materials
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Key factors in deciding which ear to implant
* **Anatomy** abnormality; nerve or cochlea related) * one ear accepts **electrical stimulation** better * Implant the **worse** hearing ear **OR** Implant **better ear** (opposite argument)- It has already benefited from hearing aid, will more readily acclimate to implant * Implant by the patients **dominate hand** * Facial nerve too close to cochlea- may pick other ear * If **no difference may want it on right (speech and hearing centers of brain on left)**
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Factors that affect CI outcomes in adults
* **Duration of hearing loss and deafness:** Longer durationof deafness = worse CI outcomes * **Age at implantation:** Poorer outcomes in elderly Pt's ↑Age = ↓Outcome Success * **Preoperative hearing status** FDA Indicated PTA does not implant performance * **Etiology:** Pt's w/ Sudden Idiopathic HL, MD, genetic → better outcome TBI,ANSD, acoustic neuroma → poorer outcomes
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# 60/60 guideline when a patient should be *referred* for a CI candidacy evaluation
*referred* for CI eval if... * Better hearing ear → **60% of less on WRS** * HL *PTA* in Better Ear → **60 db HL or worse** (unaided)
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Purpose of preoperative vs. postoperative assessments, and what each is meant to determine
* **Preoperative**: goal is to find out if the **patient is a candidate** * **Postoperative**: goal is to determine the **outcome** or the **success** of the implantation
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How to set realistic expectations for CI outcomes during preoperative counseling
Detailed counseling is vital before cochlear implant activation. * **establish a relatively conservative and realistic expectation** * **review typical performance** at activation * **Strike a balance** between conservative outlook and understanding the value of cochlear implantation. * **discuss the schedule** (audiological, medical, & rehab appt pre and post implantation,) * **familiarize patient/ family** with the implant hardware * provide **written materials**
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During CI pro operative counceling you want to strike a balance between ___ outlook and ____ __ ___ of cochlear implantation.
Strike a balance between **conservative** outlook and **understanding the value** of cochlear implantation.
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What is the most important objective prior to activation or implantation?
Helping the patient and family to **establish realistic expectations** is one of the most important objectives prior to activation. * Unfortunately, no matter how thoroughly expectations are discussed, patients and families often are discouraged with performance during the first few days of even weeks of use.
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# hint - 4 What are the key steps in the candidacy process?
1. Comprehensive Audiological Evaluation 2. Hearing Aid Verification 3. Aided Speech Recognition Testing 4. Outcome Measures
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Purpose of speech coding strategies and why they are necessary
Speech coding strategies condense the incoming signal into a form suitable for transmission while maintaining the important info
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What is the Importance of verifying hearing aid output using real-ear or simulated coupler measurements
* Hearing aids should be fit appropriately to maximize aided speech performance. * properly fit and programmed to ensure accurate aided results can be obtained
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Basic operation of a CI from sound input to auditory nerve stimulation technical terms
**Microphone** picks up & amplifies sound → converts to electrical signal → to **speech processor**, SP analyzes & converts to digital info → external transmitting coil → Power & Digital info through RF link→ **internal receiver/stimulator**, decodes digital signal → **electrical stimulation** to electrode array (cochlea) → Stimulates **Auditory Nerve** w/ biphasic current pulses → amplitude, duration, and rate of these pulses are controlled by the speech processor.
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What is speech coding strategy?
speech coding strategy determines how the **auditory signal is processed and delivered to the auditory nerve.** * Takes the acoustic signal and transfers it to an electric signal * condense the incoming signal into a form suitable for transmission while maintaining the important info
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What two major categories of speech processing strategies emerged:
* Feature-extraction strategies * Waveform strategies (taking the red line (envelope))
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What do Feature-extraction strategies do?
Extract spectral information (formants), and uses it to generate the stimulus to the electrodes. * Limitation: no significant improvements on consonant recognition scores
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Types of Feature-extraction strategies and what they do
F0/F2 Strategy: Only Extract fomant frequency and F2 F0/F1/F2 Strategy: More successful than F0/F2 based off WRS scores
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what is MPEAK (Mulitpeak) & limitation
Extracts formants (F0/F1/F2), but also HF information (800 - 4000 Hz) - showed some improvement but not enough. * Limitation: it tends to make errors in formant extraction, especially in noise
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HiResolution sound processing is available in what two commercial forms?
**HiResS and HiResP** * Clinical trials showed HiRes led to better speech recognition | Variants of CIS
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Channel interaction and its effect on spectral resolution and speech perception
In the map, you specify channels, there is frequency range (bands), ex: 100-300 which is transferred to the more apical threshold. * If the contact is stimulating that frequency region and another, it leads to distortion. * More channels/electrodes, better spectral resolution. You are getting more frequency specific. * **improving channel interaction = improving speech quality** * Decreasing channel interaction = increases quality * Less electrodes = less channel interaction
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Differences between CIS-based and n-of-m coding strategies in terms of electrode stimulation pattern
* CIS-based strategy, known as Fine structure Processing (FSP). -- Extracts spectral, envelope, and fine temporal structure information from the input signal. * N-of-m strategies are more spectral and amplitude based.
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Monopolar stimulation
* The ground electrode is placed under the temporalis muscle (outside the cochlea). * When current is sent to an electrode inside the cochlea, it flows through all tissue between it and the ground electrode. What it flows through determines impedance, due to attenuation from body tissues. * Result: Wide spread of current → less focused stimulation.
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Bipolar stimulation
* The ground electrode is an electrode on the electrode array (inside cochlea) * Uses two electrodes within the cochlea—one as active and one as ground. * Current flows only between these two electrodes, stimulating a smaller area and allow for more selective stimulation * has not proven useful and is rarely employed. * Result: More focused, selective stimulation → but not commonly used due to poor outcomes.
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Differences between monopolar and bipolar stimulation
Monopolar (MP): * Ground Outside cochlea * Broad (through many tissues) * Selectivity Less selective * Commonly used Bipolar (BP): * Ground Inside cochlea (another electrode) * Narrow (limited between two electrodes) * More selective * Rarely used (not very effective)
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What Influence does middle ear status have on implant function?
Active Middle ear effusion may delay cochlear implant surgery and has been reportedly associtaed with reduced hearing during episodes of Otitis media or negative middle ear pressure.
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Reasons for Preference for scala tympani as the site for electrode array insertion.
Take advantage of the **place-to-frequency coding mechanism** used by the normal cochlea. Scala tympani over the scala vestibuli becuase... * Larger diameter accommodates the electrode array better * Allows insertion below the fragile cochlear duct and in close proximity to the SG cell bodies * Closer proximity to the round window during surgical insertion * Less intracochlear trauma and better preservation of residual hearing * Leads to better implantation outcomes and reduced postoperative vertigo
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Why the Scala tympani has been favored over the scala vestibuli to accommodate the intracochlear electrodes?
* **Larger Diameter** * Allows **insertion below cochlear duct & close to SG Cell Bodies** * Closer to **Round window** during insertion * **Less intraccohlear trauma** & better preservation of resiudual hearing * **better outcomes** & reduced post op vertigo
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What is the Rationale for using charge-balanced biphasic pulses in CI stimulation?
* Each pulse is equal-sized negative and positive phases, **designed to deliver no net charge through the electrode at the end of the pulse** * This charge balancing avoids the accumulation of charge that could produce toxic tissue reactions
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What charge balancing avoids the accumulation of charge that could produce toxic tissue reactions?
**Charge-balanced biphasic pulses** in CI stimulation * each pulse is equal-sized negative and positive phases designed to deliver no net charge through the electrode at the end of the pulse * This charge balancing avoids the accumulation of charge that could produce toxic tissue reactions
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what are the Limitations of cochlear implants in replicating natural hearing?
CI's do not replicate * Spontaneous firing rate: * Phase Locking * Stochasticity
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# Limits of CI's Limitations of cochlear implants in replicating natural hearing Spontaneous firing rate & what it does
Spontaneous firing rate * Spontaneous activity helps **maintain sensitivity and supports coding across a wide dynamic range**. - CIs do not do this
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# Limits of CI's Limitations of cochlear implants in replicating natural hearing Phase locking & what it does
* Cochlear nerve fibers fire at the same point in each sound wave cycle, but due to their refractory period, individual fibers cannot respond to every cycle, so groups of fibers collectively encode sound frequency and pitch up to about 4000 Hz.
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# Limits of CI's Limitations of cochlear implants in replicating natural hearing Spontaneous firing rate & what it does
Spontaneous firing rate * Spontaneous activity helps **maintain sensitivity and supports coding across a wide dynamic range**. - CIs do not do this
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# Limits of CI Limitations of cochlear implants in replicating natural hearing Stochasticity & what it does
* Random but phase-related firing of individual cochlear nerve fibers. * This randomness across fibers allows neighboring groups to collectively encode the temporal structure, frequency, intensity, and duration of sounds through the volley principle, **enhancing the auditory system's ability to represent complex acoustic signals**.
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# True or false New CI's are successful because multichannel CIs can replicate the spectral analysis that occurs in the cochlea.
FALSE Success of CI is surprising because even multichannel CIs cannot replicate the spectral analysis that occurs in the cochlea. * CIs bypass the frequency selectivity of the basilar membrane and replace it by a more coarse division of the audible spectrum. * CI do not replicate Spontaneous firing rate, Phase locking and Stochasticity
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What are the different Surgical approaches used to access the scala tympani?
1. Basal turn cochleostomy 2. Round window membrane 3. Extended Round Window cochleostomy
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Describe the Cochleostomy surgical approach | SP to access the scala tympani for CI
* **drilling through the promontory** directly into the basal turn of the scala tympani - avoiding the hook area of the most proximal basal turn * Correct placement of the cochleostomy is critical for avoiding damage to inner ear structures. * An attempt should be made to limit the amount of bone dust within the cochlea to prevent new bone formation.
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Describe the Round Window surgical approach | SP to access the scala tympani for CI
* RWM is partly hidden behind a ridge from the promontory, which limits visability of RWM during surgery. * The facial recss is used in posterior tympanotomy to impant array * major boundaries of the FR are the facial nerve (FN) and chorda tympani (CT)
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What is the Facial Recess ? | SP to access the scala tympani for CI
FR is triangular space created by drilling between: * chorda tympani anteriorly * facial nerve posteriorly * incus superiorly identify the facial nerve but not to expose it. It is usually possible to spare the chorda tympani. * used as entrance for RWM electrode insertion
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Comparison of cochlear arrow trajectory between RW and extended RW approaches
* In the RW approach, the membrane's orientation directs the electrode **upward, inward, and forward**. * The crista semilunaris further **pushes it toward the osseous spiral** lamina. * To ensure smooth entry into the scala tympani, surgeons **drill part** of the **posterior round window lip and crista semilunaris.**
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What is Soft surgery?
Soft surgery refers to cochlear implantation techniques designed to **minimize intracochlear trauma, preserve residual hearing**, and **optimize electrode placement** within the ST relative to SGNs.
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Goals of soft surgery approach and its role in preserving residual hearing
Goal is to reduce disruption to delicate cochlear structures such as the **basilar membrane, osseous spiral lamina, and modiolar wall**. It focuses on * Preventing blood and bone dust entry * Using steroids * Careful surgical site selection * Minimizing perilymph leakage and suctioning * Controlling insertion depth
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soft surgery approach It focuses on what?
* Preventing blood and bone dust entry * Using steroids * Careful surgical site selection * Minimizing perilymph leakage and suctioning * Controlling insertion depth
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Early complications following CI surgery
* **Facial N Injury**: FN Palsy or paralysis * **Alteration of Taste**: metallic taste * **Infection**: Bacterial meningitis * **Dizziness**: tinnitus or vertigo * **Wound dehiscence / Flap necrosis** aggressive thinning of flap - Most serious compication & Requires device removal. * **Early device failure** * **CSF leak (gusher)**: CSF leak in CI
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Late Complications following CI surgery
* Extrusion / Exposure of Device * Displacement of electrodes * Late device failure * Otitis media * Meningitis
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# True or false Cochlear implantation recipients are at high risk of developing Pneumococcal Meningitis.
TRUE It is can be a late complication post implantation
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Two types of electrode misplacement
* Lateral Wall Trauma * Osseous Lamina Fracture
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Impact of electrode misplacement on implant outcomes * Lateral Wall Trauma
One of the **most commonly** reported types of insertional damage . Lateral wall trauma may occur in several ways * When the basilar membrane is involved, often torn at lateral wall & can cause **penetration of the electrode into scala media.**
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Impact of electrode misplacement on implant outcomes * Osseous Lamina Fracture
* Osseous lamina fracture would sever the dendrites of spiral ganglion cells eventually leading to **ganglion cell degeneration in the affected area.**
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Soft Failure
* Slow Decline * Uncommon * declining performance, aversive symptoms such as a popping or shocking sensation or intermittent function * only be confirmed by removal,examination & identification
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Solution for soft failure
Reimplantation with another device * Relief of symptoms following reimplantation of a new device strongly supports the diagnosis.
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Hard Failure
* Device Malfunction * easily confirmed with the available assessment tools * Symptoms: ↓Hearing performance & integrity testing shows malfunction
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What impedance is
Electrode impedance is a measure of the **opposition to electrical current flow across an electrode when a certain voltage is applied** * Opposition to flow
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clinical purpose of impedance in cochlear implants
* Idenify electrode failure * Verification of voltage compliance * Monitor electrode function * Evaluate intraoperative to post op changes * Changes across follow ups
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Definitions, causes, and identification of Open Circuits
**Definition**: incomplete path for current to flow, or a discontinuous circuit. **Causes**: * Broken electrode contact * Broken lead wire * ossification/buildup * air bubble **Impedance** * HIGH * 30+ kohms
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Definitions, causes, and identification or short circuit
**Definition**: low resistance between two points in a circuit that differ in potential which typically are separated by higher resistance → increase in current flow **Causes**: * kinked or curled array * Excessive distortion or tension on the electrode array. * Electrode lead wires that are touching within the electrode carrier due to damaged insulation. **Impedance** * Low * less than 1 (0 or 0.5)
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Definitions, causes, and identification Partial short circuit
**Definition**: relatively low resistance resulting in increased current flow, but still higher impedance for a true short circuit. **Causes**: * small tears or fractures in the silicone surrounding the electrode **Impedance** * Low * altering the impedance * zigzag pattern
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Impedance of >30 kohms indicates what?
**Open circuit** * Broken electrode contact * Broken lead wire * ossification/buildup * air bubble
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Low and alternating impedances indicate what
Partial short circuit * small tears or fractures in the silicone
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excessively low impedance; >1 (0 or 0.5)
Short circuit * kinked or curled array * Excessive distortion or tension on the electrode array. * Electrode lead wires that are touching within the electrode carrier due to damaged insulation.
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Short and Open circuit management
* **disabled** but re-evaluated after a period of implant use. *
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# True or false. Electrode impedances are often high at initial activation but usually decrease with electrical stimulation.
TRUE Due to accumilation around electrode away
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Partial short circuit management
may or may not be disabled, depending on the **extent** to which **performance is affected**
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CIs have constant current determined in the software, and the amount of voltage (coming from the battery) changes based on the ____ what?
CIs have constant current determined in the software, and the amount of voltage (coming from the battery) changes based on the **impedance of the electrode.**
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What is voltage compliance
The **voltage is limited by the battery** - this is called voltage compliance * Using a battery with higher voltage capacity can help avoid reaching the compliance limit. 0 once you reach compliance limit - you cannot increase any more.
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The maximum amount of electrical current available to stimulate an electrode contact is determined by what law:
Ohm’s law Voltage (V) = Current (I) X Resistance (R)
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If a recipient uses a map with electrodes that are “out of voltage compliance” what happens?
* Speech recognition and sound quality may be reduced. * Loudness may be unbalanced across the electrode array. * The user may experience non-auditory effects, such as facial nerve stimulation, due to maximum current amplitude.
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Expected/normal impedance fluctuations
* Impedance lowest at the time of surgery * After surgery impedance increases due to inflammation * Steroid use during surgical insertion reduce fibrous tissue growth and lower impedance. * Once the implant is stimulated, impedance typically decreases over time. * Impedances should remain stable one to three months post-activation
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Impedances should remain stable ___ to ___ months post-activation
Impedances should remain stable **1** to **3** months post-activation
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Factors affecting impedance measurements...
* **electrode contact** * **electrode lead that is coupled to the contact** * **Surrounding medium**, including: Cochlear fluids Surrounding tissues Electrolytes Macrophages Proteins
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Purpose of electrode conditioning
EC is presentation of low-level current to each electrode to remove air bubbles, protein buildup, and so forth.
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When is electrode conditioning is typically used?
* Prior to testing in the operating room * At initial activation * At a programming session preceded by a prolonged period of nonuse * When activating electrodes were previously disabled and reactivated
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Names of the clinical programming software used by the three manufacturers
* Cochlear: Custom Sound * Advanced Bionics: SoundWave * MED-EL: Maestro
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programming software for cochlear
Custom Sound
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programming software for AB
Sound Wave
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programming software for MED-EL
Maestro
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What is Input Dynamic Range (IDR)?
range of acoustic inputs that are mapped to the user's electrical Dynamic range
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Lower IDR is what
Lower IDR → Threshold of electrical stimulation.
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Upper IDR is what?
Upper IDR → maximum electrical stimulation level
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the lower end of the IDR usually is set to what?
lower end = 20 to 30 dB SPL
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upper end of the IDR is set to what?
Upper end = 65 to 85 dB SPL
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Typical IDR effect of sensitivity settings on soft sound audibility
* Controls the microphone gain in the sound processor. * Adjusts the input signal level before frequency analysis. * Works to shape how acoustic signals are mapped into the user’s electrical DR. * ↑ sensitivity allows softer sounds to be included in the mapped input range, while ↓ sensitivity excludes lower-level sounds.
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Frequency allocation table controls what?
Frequency allocation table controls **how frequencies are delivered across the active channels**.
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Frequency allocation tables; how disabling electrodes changes the frequency-to-electrode assignment
* They can also choose from four frequency allocation tables based on different psychoacoustic models. * Current methods include anatomy-based assignment. * **If an electrode is turned off, its frequencies are reallocated to remaining active electrodes**.
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# True or false Optimal stimulation rate can vary across individuals
TRUE
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Effect of stimulation rate on temporal resolution
**High stimulation rates improve access to fine temporal details in sound. =** Enhanced temporal resolution * Better speech understanding in noise * Improved music perception and appreciation * Recognition of vocal pitch * Potential for improved pitch perception
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Effect of stimulation rate on pitch perception
**Higher rates can result in a higher pitch perception** and increase loudness due to temporal summation.
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Effect of stimulation rate on loudness,
**Higher rates** can result in a higher pitch percept and **increase loudness due to temporal summation.**
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Electrode spacing may influence a recipient’s performance with higher stimulation rates at higher rates...
Closer spacing increases the risk of temporal channel interaction, which can degrade performance.
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# True or false It most important to select a magnet strength that is sufficient to prevent the transmitting coil from repeatedly falling off of the recipient’s head.
FALSE * It is important to select a magnet strength so the transmitting coil does not repeatedly falling off of the recipient’s head. * It is **more important that the magnet strength is not too great because excessive adherence of the coil may compromise circulation to the skin underneath the coil.**
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Prolonged excessive magnet strength may cause __ ___under the coil, potentially leading to skin flap breakdown and requiring reimplantation.
Prolonged excessive magnet strength may cause **skin necrosis** under the coil, potentially leading to skin flap breakdown and requiring reimplantation.
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# Determining appropriate magnet strength Middle-aged males and obese recipients need what magnet strength?
Middle-aged males and obese recipients may require **stronger magnet strength due to thicker skin flaps.**
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# Determining appropriate magnet strength Young children and elderly women often need what magnet strength?
Young children and elderly women often need **weaker magnet strength due to thin skin flaps.**
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How minimum stimulation levels are defined by AB
Advanced Bionics: lowest amount of electrical stimulation a user can detect with 50% accuracy; T levels. Can be locked to 10% of the DR. * **Threshold → T Level**
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How minimum stimulation levels are defined by cochlear
Cochlear: the minimum amount of electrical stimulation the recipient can detect 100% of the time; T levels. * **little Above Threshold → T Level**
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How minimum stimulation levels are defined by MED-EL
MED-EL: highest level at which a response is not obtained; THR. Can be locked to 10% of the DR. * **right below Threshold →THR**
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How upper stimulation levels are defined by AB
Advanced Bionics: most comfortable; M levels
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How upper stimulation levels are defined by MED-EL
MED-EL: very loud but comfortable; MCL
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How upper stimulation levels are defined by Cochlear
Cochlear: loud, C levels
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Setting threshold level
* Start with LF electrode; give them an audible sound and then ascend to find the threshold. * Used to prevent the t tail * Use larger steps early on, and smaller steps for fine tuning after a week.
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List Setting threshold level Approaches
* Traditional threshold measurement techniques (modified Hughson-Wastlake) * Count-the-beep method * Psychophysical loudness scaling * Threshold estimation
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Approaches for Setting upper stimulation levels
* Psychophysical loudness scaling * Global increase in upper stimulation levels while the user listens to speech
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Setting upper stimulation levels w/ Psychophysical loudness scaling
* Pt is asked to indicate the loudness percept of the stimulus by pointing to a loudness scale chart. * Clinicians gradually increase the level of the programming stimulus until the pt reports that it is comfortably loud. | Like MCL's on Audio
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Setting upper stimulation levels w/ Global increase in upper stimulation levels while the user listens to speech
* Upper stimulation levels will be set where speech and environmental sounds are most comfortable.
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C levels are critically important for what?
* Preventing sounds in the environment from being uncomfortably loud. * Supporting speech recognition and sound quality * Enabling prelingually deafened children to monitor their own voice and develop intelligible speech
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negative consequences to Improperly programmed T levels can lead to
* too low, the recipient will **not have adequate audibility** of low-level or soft sounds. * too high (i.e., above the real threshold), the recipient may experience **excessive ambient noise** and a reduced electrical dynamic range.
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negative consequences to Improperly programmed upper stimulation levels
* Discomfort * Poor speech recognition * Reduced overall sound quality * An aversive reaction to CI * Poor overall outcomes, especially in children relying on auditory feedback for speech development
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Loudness balancing aims to what?
Loudness balancing aims to ensure **equal loudness at upper-stimulation levels in order to optimize speech recognition and sound quality** by maintaining the typical loudness/intensity relationship that exists for different phonemes.
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Three objectives are associated with electrode sweeping:
* Measuring sound quality * Determining appropriate pitch transitions * Confirming equal loudness across all channels
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Loudness Balancing Procedure
* upper-stimulation level for two channels at a time. * begins with the most apical (lows/inside) channel and progresses toward the more basal (high) * PT attend to loudness and not the pitch * adjustment to stimu level **always** should be to the **second electrode**
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If recipients have a difficult time tolerating high-frequency how do you conduct loudness balancing?
For recipients who have a difficult time tolerating high-frequency stimuli, conduct from **high to low frequencies**. Basal → Apical
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Sweeping involves the sequential presentation of the programming stimulus across ___ electrode contacts in the array, starting from __ to __
Sweeping involves the sequential presentation of the programming stimulus across **all** electrode contacts in the array, starting from **lows** to **highs**
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Loudness Balancing Clinical Use
* Sweeping- depends on your purpose * Loudness balancing, sound quality & speech understanding. To make sure the frequencies are balanced Pitch & comfort
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Name & Goal of the anatomy-based fitting by MED-EL
**Otoplan** Goal: To **reduce spectral mismatch through imaging.** * Identify where each electrode contact is * Use that information to apply a place-specific map with individualized center frequencies for each contact that is a closer match to the natural frequency-place.
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Approaches used to manage non-auditory stimulation in CI patients
1. Try lowering the amplitude 2. Increase the pulse width 3. Turn off Electrode * Cochlear → monopolar to bipolar: more focused and reaches less neurons * MED-EL → triphasic stimulation: disperses the current between two reference electrodes instead of just one.
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Evaluate progress for Optimization Phase
* Up to one month: Informal speech perception measures * One to three months: CNC words in the implanted ear and in the everyday listening condition.
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Optimizing the map during the Optimization Phase
**Sweeping** * levels have been set sweep at the upper-stimulation level * detect any channel-specific undesirable effects such as loudness discomfort or a non-auditory response **Loudness balancing** * Loudness balancing should be completed whenever possible after setting upper-stimulation levels in live speech mode. * loudness balancing around 6 to 7 years - youngest
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Patient should be able to what during the Optimization Phase?
* map allows gives to access quiet spoken language while not exceeding levels of comfort. * wear consistently min of 10 hours per day. * hear ≤ 30 dB HL * hear to at least 30 feet away * able to tolerate loud sounds
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Child may smile, vocalize, or seem pleased with the sound
Positive response pattern at activation
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How does a patient move from Optimization to the Maintenance phase
Patients enter the maintenance phase when ... * SF thresholds better than 30 dB. * 10 hours +/ day with data logs. * Post-operative CNC word score in the implanted ear is 56% or better; OR. the patient’s scores in the implanted ear have improved by at least 20% when compared to scores obtained in that ear prior to implantation If the patient has not yet met these milestones or if other concerns exist, they can remain in the optimization phase for further support.
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What to expect during Maintenance phase
* SF thresholds better than 30 dB. * 10 hours +/ day with data logs. * Post-operative CNC word score in the implanted ear is 56% or better; OR. the patient’s scores in the implanted ear have improved by at least 20% when compared to scores obtained in that ear prior to implantation
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List the three typical response patterns children may show at activation
positive, neutral, or distressed
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no visible response, even when sound is clearly audible.
Neutral or non observable reaction response patterns at activation
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* The child may cry, remove the device, or seek comfort. * This is often due to sudden exposure to a new sensory input
Negative: Upset or distressed response pattern
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Importance of full time device use in young children and why easing into wear time is not appropriate
* Early auditory input is a neurodevelopmental emergency — the **brain requires consistent sound exposure to develop speech and language pathways**. * Missing input during this critical period can **cause irreversible delays in auditory and spoken language development.**
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Missing input during this childs critical period can cause ___ delays in __ and __ __ development
Missing input during this critical period can cause **irreversible** delays in **auditory** and **spoken language** development
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Techniques used to estimating upper-stimulation levels in young children
* Psychophysical loudness scaling * Global adjustment in live speech * Flat MAP * Flat MAP with fine tuning * Estimation from objective measures
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Estimation from objective measures
* Using play behavior to guide upper-stimulation level settings * In live speech it may be helpful for children to play with noise makers. * **Child Plays with toys = Level too low** * **Child Stops Playing = uncomfortable level, too loud**
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Flat MAP with fine tuning
* begin with a flat MAP or global increase from T levels and then fine-tune based on the recipient’s feedback. * Upper-stimulation levels are refined to improve sound quality and comfort based on the user’s feedback. Advantages: has the advantage of possibly improving sound quality and recipient performance Limitations: Loudness may still be uneven across electrodes
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Flat MAP
* Start with flat stimulation levels (T + C), initially inaudible to the child. * live speech mode, gradually increase stimulation * Identify the level where the child first responds to sound—this is used to set T Levels. * Continue increasing upper-stimulation levels while observing the child’s responses to sounds until desired loudness is achieved. * Levels should reflect a typical electrical DR for the implant being used. * Advantages: Quick and easy to implement during live speech mapping and can serve as a starting point for programming in difficult cases or with limited time. * Limitations: Using the same intensity across all channels may result in uneven loudness perception.
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Global adjustment in live speech
“Building From the Floor” Approach * Programming begins by measuring minimal electrical detection levels. * Upper-stimulation levels are then globally increased from the T Level profile using live speech mode. * Clinicians observe the child’s behavior for signs of discomfort or overstimulation * If the child shows signs of distress, programming should be immediately stopped and levels adjusted to ensure comfort.
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Psychophysical loudness scaling
* Used primarily with older children (8–9 years and up) and adults * Present pulsed electrical signals to individual electrode(s), increasing loudness gradually until patient reports to sound is loud. * Procedure is repeated across multiple electrodes to determine frequency-specific levels. * Advantages: help identify if a child is struggling to access sounds in a specific frequency range or finds a certain channel aversive. * Limitation: Requires consistent reliable responses
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Reasons to avoid routine increases in upper-stimulation levels in children without a clear evidence of under stimulation
* Routine increases can lead to stimulation levels that exceed those used by adults * Overstimulation could hinder long-term auditory performance
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Recommended follow-up schedule for pediatric CI users
First year of device use: Initial activation: 1–4 weeks 1 week post initial activation 2 months post initial activation 3 months post initial activation 6 months post initial activation 9 months post initial activation 12 months post initial activation After the first year * every 3 mos if not reliable * Every 6 to 12 mos if reliable
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ESRT: Electrically -Evoked Stapedial Reflex Threshold
* contraction of the stapedial muscle in response to intense electrical stimulation from the cochlear implant. * Objective and quick to administer * Preferable methods for setting upper-stimulation levels in children as precise loudness scaling and balancing are often unreliable before age 8.
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ESRT Procedure
* Place an acoustic immittance probe (reader) into contralateral ear to the CI * Record acoustic admittance while presenting stimulus to the implant in an ascending manner. * Decrease Stimulation levels to avoid loudness discomfort before activating the sound processor in live speech mode. * Gradually increase the upper-stimulation levels while monitoring. Adjust levels until optimal loudness and sound quality are achieved.
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ESRT Clinical Applications
* ESRT for predicting upper-stimulation levels * ESRT is within an average of 9 clinical units of upper-stimulation levels
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Relation between levels estimated using ESRT procedures and behavioral levels across manufacturers
ESRT is lower than levels set by behavioral measures, making it a safer starting point.
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ESRT limitations
* **middle ear anomalie**s may interfere w/obtaining a measurable response. * If a contralateral ESRT is not measurable, testing may be attempted in the ipsilateral ear. * ESRT measurements may be more **problematic** to measure in **bilaterally implanted** recipients because both ears have undergone surgery.
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How ESRT can be used to identify overstimulation in children who are unable to provide reliable feedback
Electrical Stimulation Threshold needs to be **at or below your ESRT but you are never above** * If they are way above red line = over stimulation * Below Red line = lots Under stimulation
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What EABR is and how it differs from ECAP and acoustic ABR, and its clinical applications
EABR is a neurophysiological test measuring auditory brainstem activity in response to electrical stimulation from a CI. * EABR is recorded from scalp electrodes in response to electrical stimulation from the cochlear implant. * Reflects synchronous firing of neurons in the auditory brainstem. * Waves III and V are typically present, with wave V being most prominent. * **No latency shift** * Waves are generated in the pons and midbrain regions.
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EABR VS ABR
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Why is EABR not as commonly used anymore?
We do not need EABR when **telemetry** is present in CI’s because the function and responsiveness is already determined though impedance or ESRT’s * Telemetry: communication between the implant and the hardware; radiofrequency
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Clinical use of EABR
* confirm implant function or auditory responsiveness in recipients without telemetry systems. * With the development of telemetry and ECAP, the routine clinical use of EABR has declined.
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ECAP: Electrically-Evoked Compound Action Potential
synchronous response from electrically stimulated auditory nerve fibers. (ECochg) * neural response from the distal cochlear nerve fibers and/or spiral ganglion cell bodies of the cochlear nerve. * ECAP give you upper and low levels
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ECAP: Electrically-Evoked Compound Action Potential in the manufactures
* ART (MED-EL), * NRI (AB), * **NRT (Cochlear)**
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ECAP's origin
* Spiral Ganglion Neurons are the most likely generator of the ECAP. * A neural response from the distal cochlear nerve fibers and/or spiral ganglion cell bodies of the cochlear nerve. * (ECochg)
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ECAP's morphology
ECAP is recorded as a negative peak (N1) at about 0.2 - 0.4 ms following stimulus onset, followed by a much smaller positive peak (P2) or plateau occurring at about 0.6 - 0.8 ms.
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ECAP's properties, and the general stimulation and recording setup
ECAP is essentially the electrical version of Wave I of the ABR with Greater amplitude Shorter latency No myogenic artifact Unaffected by sleep and anesthesia. No need for sedation when measured in children.
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The three major limitations of ECAP recordings
* **Current source saturation**: greater distance results in lower voltage. * **Poor reference contact**: Poor contacts = high impedance = recording more difficult andartifacts bigger. * **Stimulation artifact**
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ECAP threshold is measured on all active intracochlear electrode contacts
Off-set method:
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ECAP threshold is measured for every intracochlear electrode contacts
Live Speech method
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The three different types of measurements that can be obtained using ECAP recording
**Amplitude to growth function**: measuring with ECAP threshold **Refractory function** **Spread of excitation**: Overlap between two electrode * Further = less excitation * Closer = more excitation
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Auditory Brainstem Implant (ABI):
Surgically implanted device that directly stimulates the cochlear nucleus of the brainstem.
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Two hypotheses for ABI differences in performance:
Difference in speech understanding between CI and ABI is caused by the * **ABI bypassing or distorting activation of specialized neural circuitry** occurring in the CN. * ABI does not make selective contact with the tonotopic dimension of the CN which limits the number of independent channels of spectral information.
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# * Current FDA-approved indications for ABI
Inclusions (must meet both): 1. At least 12 years of age or older who have neurofibromatosis Type II 2. Who are rendered deaf due to bilateral resection of neurofibromas of the auditory nerve
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FDA primary contraindications for ABI
* Children without NF2 * Anatomy Factors * Physiological factors
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Related risks for ABI
* Standard surgical risk * Meningitis (risk with all neurosurgery) * CSF leak * Unsuccessful hearing enhancement * Unknown long-term effects of electrical stimulation
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two main surgical approaches used for ABI placement
Translabyrinthine & Retrosigmoid approach:
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# ABI surgical approache Involves removal of the mastoid bone behind the auricle as well as the semicircular canals of the inner ear.
Translabyrinthine approach:
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# ABI surgical approache Desirable because it provides good visualization of the lateral recess of the fourth ventricle and the facial nerve and does not require retraction of the cerebellum.
Translabyrinthine approach:
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# ABI surgical approache Eliminates the possibility of preserving residual hearing.
Translabyrinthine approach
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# ABI surgical approache Requires retraction of the cerebellum and does not provide complete visualization of the facial nerve.
Retrosigmoid approach
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# ABI surgical approache Less invasive, enables removal of skull-based tumors provide improved visualization of the cochlear nerve.
Retrosigmoid approach
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# ABI surgical approache Involves an incision made behind the auricle and accessing the brainstem and cerebellum through a small opening that is made near the base of the skull.
Retrosigmoid approach
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Site of electrode placement for ABI
On the cochlear nucleus
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Why use EABR during ABI placement?
* Confirms stimulation from the electrode array activates the auditory brainstem pathway, as reflected in the eABR waveforms * Assists in optimizing electrode placement by confirming effective stimulation of the CN
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Challenges in electrode array placement
* The full surface of the CN is not visible during surgery * No clear anatomical landmarks * Anatomical variations between patients * Removal of large tumor can distort surrounding anatomy
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How non-auditory sensations are managed by the programming audiologist.
If minor, the following adjustments should be considered: * Reduce current level * Increase the Pulse Width of the electrical pulse * Change the electrode coupling mode to avoid the non auditory side effect. * Reduce pulse rate * If current level reduction does not help, the affected electrodes should be disabled. Non-auditory sensations often decrease over time
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Types of non-auditory sensations patients may experience during device programming
* Auditory perception * Tinnitus or ringing sensation * Other sensations (e.g., paresthesias, vertigo, dizziness) * Any combination of auditory and non-auditory effects
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Factors that influence ABI outcome
**Placement of the device & anatomy** * Motivation to hear - Commitment to rehabilitation * Psychological readiness * Acceptance of device limitations * Anatomical status * Family and support system
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Persistent inflammation following electrode insertion trauma during cochlear implantation can result in what?
* **Development of fibrosis and calcification** * Immediate inflammation is normal but if persists the inflammatory response will become subacute and pass into a chronic phase. Development of fibrosis and calcification and even new bone formation.
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Persistent inflammation following electrode insertion trauma during cochlear implantation can result in which of the following complications?
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Which of the following factors can influence the maximum current required to achieve high stimulation levels in a cochlear implant system? Electrode impedance Voltage compliance limits Distance from target neural elements All of the above
ALL OF THE ABOVE * Electrode Impedance will be variable across electrodes and determined by the impedance at each electrode * Voltage: Once stimulation reaches the voltage compliance limit, additional current cannot be delivered. As a result, increasing the current level in the programming software will not result in loudness growth. * Distance from target neural elements: Not in notes but i would say yes because current would need to flow though fluid and tissues and greater distance would = reduced stimulation.
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Which speech coding strategy emphasizes fast pulse stimulation and temporal detail? * ACE * SPEAK * MPEAK * CIS
CIS * The CIS strategy uses high-rate pulsatile stimuli to capture the fine temporal details of speech.
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Which mode is most effective for detecting shorted electrodes during impedance testing in cochlear implants? * Monopolar * Common ground * MP2 * Tripolar
Common Ground * Common Ground: Electrical current is delivered to an active intracochlear electrode, and all of the remaining intracochlear electrodes serve as the collective return .
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Which of the following is *least likely* to be considered a sign of soft implant failure? * Annoyance with high-frequency stimulation * Head-hitting behavior in young children * Pain radiating down the neck * Perception of static or noise
Annoyance w/ HF Stimulation * becuase annoyance with HF stim is common and not just a sign of soft failure - Dr.G
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How does the ACE strategy differ from SPEAK? * Uses analog pulses * Operates at higher stimulation rates * Uses lower stimulation rate * Eliminates envelope detection
Operates at higher stimulation rates * **ACE (Advanced Combination Encoder) uses higher stimulation rates compared to SPEAK.** * ACE is an N-of-M strategy used in Cochlear Ltd. implants and is currently the default coding strategy for most users. – selects highest envelope signals for each cycle of stimulation * ...Similar to SPEAK but it uses much higher stimulation rates. * Most recipients perform better with ACE than with SPEAK.
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Which of the following is least likely to result in abnormally high impedance? * Kinked electrode array * Broken electrode contact * Air bubble or ossification * Prolonged electrode deactivation
Kinked Electrode Array * Kinked electrode array = Short circuit -- Short circut = low impedance (lower than 1) * Broken electrode contact = Open Circuit * Air bubble or ossification = Open Circuit * Prolonged electrode deactivation = Impedance can increase for electrodes that are not stimulated for a period of time
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# True or false Telemetry is the bi-directional transfer of data between the cochlear implant and the programming hardware via radio-frequency signals.
TRUE * Telemetry is the bi-directional communication of data between the programming hardware and the implant, using radio-frequency code. * Telemetry simply means data transmission via radio frequency from a source to a receiving station * Telemetry means receiving data from the implant to ensure that it works within the specification
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In the n-of-m coding strategy, what determines which electrodes are activated? * Random selection * Low-frequency dominance * Electrodes with the highest signal amplitudes * ser preference settings
Electrodes with the highest signal amplitudes
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In standard cochlear implantation, the electrode array is intended to be inserted into which cochlear scala? * Scala Tympani * Scala media * Scala vestibuli * Modilous
Scala Tympani * The electrode array is typically inserted into the scala tympani, which provides the safest route and closest proximity to the neural elements of the cochlea.
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Persistent inflammation following electrode insertion trauma during cochlear implantation can result in which of the following complications? * Development of fibrosis and calcification * Lateral wall damage * Reduced fibrosis and calcification due to increased blood flow * Disruption of the basilar membrane, allowing mixing of perilymph and endolymph
Development of fibrosis and calcification * Immediate inflammation is normal but if persists the inflammatory response will become subacute and pass into a chronic phase. **Development of fibrosis and calcification and even new bone formation.**
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Which of these is a commercial version of HiResolution processing?
HiResP * HiResolution sound processing is available in two commercial forms, HiResS (sequential stimulation) and HiResP (partial stimulation).
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Which of the following is used in cochlear implant technology to prevent charge accumulation and reduce the risk of tissue damage? * Monophasic current pulses * Constant voltage stimulation * Constant current stimulation * Charge-balanced biphasic current pulses
Charge-balanced biphasic current pulses * Each pulse is made up of equal-sized negative and positive phases, designed to deliver no net charge through the electrode at the end of the pulse. * Localized electrochemical reactions are reversed during the second phase of the biphasic pulse, ensuring that no net electrochemical products are formed. * **This charge balancing avoids the accumulation of charge that could produce toxic tissue reactions.**
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# True or False Modern cochlear implant systems typically incorporate dual microphones to improve listening in noise.
True * “Adaptive directional microphone technology & Speech Tracking” * “Intelligent Sound Adapter 2.0 Noise Reduction”
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Which cochlear implant manufacturer currently offers the longest electrode array? * MED-EL * Cochlear * Advanced Bionics * They all offer arrays of the same length
MED-EL * The longer electrode array of MED-EL arrays may further support FSP by targeting low-frequency nerve fibers in the apical cochlea.
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What maintains alignment between the internal and external components of a cochlear implant system? * RF link * Bluetooth * Magnet * Telecoil
Magnet * Magnet to locate and maintain connectivity between internal and external components.
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Which component of the cochlear implant system is responsible for decoding the radio frequency (RF) signal?
Receiver-stimulator package * The receiver/stimulator decodes the digital signal and delivers electrical stimulation pulses to the electrode array implanted inside the cochlea.
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# True or False Atraumatic surgical technique includes suctioning of perilymph.
FALSE
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What type of acoustic feature does the F0/F1/F2 strategy primarily focus on? * Envelope cues * Temporal rhythms * Spectral formants * None of the above
Spectral formants * **Use feature extraction algorithms to extract type of spectral information, such as formants, to use this information to generate the stimulus to the electrodes** * F0/F1/F2 strategy: available in 1985 with the Nucleus wearable speech processor (WSP). * Average scores on word recognition increased from 30% correct with the F0/F2 processor to 63% correct with the F0/F1/F2 processor.
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Which process in the speech processor separates the signal into multiple bands? * Compression * Filtering * Modulation * Amplification
Filtering * **Filtering: used to divide the pre-emphasized signal into multiple frequency bands** using a filter bank, designed to mimic the natural tonotopic organization of the human cochlea. This separation also allows each band to be processed independently for targeted stimulation
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Which component of the cochlear implant system directly stimulates the auditory nerve fibers? * Transmitting coil * Internal receiver stimulator * Electrode array * Directional microphone
Electrode array * The “electrode array” refers to the distal part of the device that carries the electrode contacts and is inserted into the cochlea. * Electrode contact: describes a physical contact in the internal device electrode array where stimulation is delivered to the auditory nerve fibers. * **Electrode array: Stimulate the auditory nerve fibers in the cochlea**
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# True or False The design and geometry of electrode contacts can influence the distribution of the electrical current.
True * Shape and design of each electrode contact can affect the shape of the resulting current fields.
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Compression in a CI system is used to: * Decrease the number of electrodes * Reduce the frequency of the signal * Improve the microphone performance * Match the acoustic signal to electrical dynamic range
Match the acoustic signal to electrical dynamic range * Compression: used to compress the incoming signal into the narrow electrical DR to make it suitable for stimulation because of the large difference between the acoustic and electric dynamic ranges.
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In N-of-M strategies, “N” refers to: * Electrodes selected for stimulation * Total filters * Frequency bands * Pulse cycles
Electrodes selected for stimulation
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The following impedance measurements suggest which of the following device issues? * A normally functioning device * A kinked electrode array * A tear in the silicone insulation * A broken lead wire
**A tear in the silicone insulation** * are bundled separately from each side of the internal receiver-stimulator. Depending on where **silicone fractures** occur,
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# MEI Transducer Piezoelectric Process
Mechanism: * Piezoelectric materials oscillate when subjected to electrical stimulation and generate electrical voltage when physically displaced (by vibration or pressure). HA * When coupled to the middle ear, piezoelectric transducers deliver mechanical energy to the ossicles. They convert electrical signals into mechanical vibrations to stimulate hearing OR (depending on configuration) can convert mechanical vibrations into electrical signals for analysis or feedback.
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Transducer Piezoelectric Pros and cons
Advantages: ✅ **No external power source** required when used in sensor mode (to detect vibrations). ✅ **Highly stable and durable** due to solid-state design and lack of moving parts in the traditional sense. Limitations: ❌ **Limited output and narrow bandwidth**, which may not provide sufficient amplification for individuals with moderate to severe hearing loss.
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# True or False active middle ear implants, piezoelectric transducers typically convert electrical signals into mechanical vibrations, not the other way around (unless used as a sensor).
TRUE * active middle ear implants, piezoelectric transducers typically convert electrical signals into mechanical vibrations, not the other way around (unless used as a sensor). * hearing amplification, external power is usually required to drive the signal through the system, even if the piezoelectric element itself doesn't need much power or a magnetic field to function.
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Transducer Electromagnetic Process
Mechanism: * Electromagnetic MEIs use electromagnetic induction by placing a biocompatible magnet on the ossicular chain or other middle ear structure, near a stationary wired coil. Function: * When electrical current flows through the coil, it creates a changing magnetic field. This field causes the magnet (attached to the ossicles) to oscillate, which directly stimulates the ossicular chain, converting electrical signals into mechanical energy that the ear perceives as sound. Coil is fixed in position & magnet moves The coil is fixed in the middle ear cavity (usually attached to nearby bone or tissue). → The magnet moves, transferring vibratory energy to the ossicles.
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Transducer Electromagnetic Pros and cons
* ✅ Higer output than pizeoelctric * ❌ Output depends on the magnet-coil distance (proximity is critical for consistent performance). * ❌ Head and jaw movements may momentarily alter this distance, potentially affecting sound output or signal transmission.
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Electromechanical Process pros and cons
Magnet and coil are housed together. * ++ They deliver higher output levels and wider frequency responses compared to electromagnetic transducers. * ++ They are not affected by changes in magnet-coil distance. * -- More complex design and more prone to mechanical failure.
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Bone conduction devices Candidacy criteria for patients with CHL, MHL
* Calculate the average BC thresholds and the average air-bone gap * Average BC threshold at .5, 1, 2 and 3 kHz; patient is a candidate if 65 dB HL or better * Additional considerations: Average air-to-bone gap at .5, 1, 2 and 4 kHz; patient is a candidate if > 30 dB -- **need to have bone gap better results if ABG is 30+** Age: * Surgical solution: 5 years and older * Non-surgical solutions: any age
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Bone conduction devices Candidacy criteria for patients with SSD
* Poor ear: Profound sensorineural hearing loss 80 dB HL or worse * Good ear: Air conduction PTA (0.5,1,2,3 kHz) 20 dB or better Age: * Surgical solution: 5 years and older (Osia, Baha, Bonebridge). * Non-surgical solutions: any age * This is essentially a cross device, you have to make sure one cochlea is good so they can hear with bone conduction.
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Required procedures prior to conducting a candidacy assessment - CI | Detailed
Comprehensive Audiological Evaluation * Otoscopy * Acoustic Immittance * Air conduction * 125 - 8,000hz w/inserts Hearing Aid Verification * Choose and fit HA's to optimize WRS performance * Listening check and or electroacoustic test for internal noise or distortion * REM to verify output matches targets * Verify output with a calibrated speech signal at 60/65 dbSPL Aided Speech Recognition Testing * Speech discrimination score are key for candidacy * Calibrate - very important * Aided Speech recohnition is evaluted w/ the minimum speech test battery (MSTB) * CNC & AzBio (RE only,LE only & bilateral if needed) Outcome measures * Patient reported outcome measures. * Questionnaires.
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Procedures and protocols for determining candidacy in traditional candidates and those with good low frequency hearing (EAS), SSD, and AHL
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Lower stimulation levels
Least amount of stimulation a recipient can detect when electrical signal (biphasic pulses) are delivered to individual electrode contacts.
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Upper stimulation levels:
Upper limit of electrical stimulation.
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Pulse width
Duration or length of one single phase (typically in microseconds)
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Current amplitude:
Current amplitude per phase of a biphasic electrical pulse
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Pulse rate:
Refers to the number of biphasic pulses that are delivered to an individual electrode contact within 1 second (PPS).
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Channel gain:
Adjustment to channel gain controls the amplification provided to the signal in a channel specific and therefore frequency specific manner. The effect of gain occurs prior to the processing of the signal.
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Input Dynamic range:
range of acoustic inputs that are mapped to the user's electrical DR
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Electrical Dynamic range
Difference between the CI user’s perceptual threshold and most comfortable level for electrical stimulation.
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Frequency allocation:
Frequency allocation table controls how frequencies are delivered across the active channels. * They can also choose from four frequency allocation tables based on different psychoacoustic models. * Current methods include anatomy-based assignment. * If an electrode is turned off, its frequencies are reallocated to remaining active electrodes.
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Consequences of improperly set lower and upper stimulation levels
Inaccurate T-level programming * If set too low, the recipient will not have adequate audibility of low-level or soft sounds. * If set too high (i.e., above the real threshold), the recipient may experience excessive ambient noise and a reduced electrical dynamic range Inaccurate upper stimulation levels * Discomfort * Poor speech recognition * Reduced overall sound quality * An aversive reaction to CI * Poor overall outcomes, especially in children relying on auditory feedback for speech development
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Signs of overstimulation in children
* Holding his or her breath * Exhibiting facial expressions of mild concern * Looking to a caregiver for reassurance * Tensing or stiffening of the body or shoulders * Playing more actively or aggressively * Wringing hands, clothes, or toys * Producing blinks in response to the stimulus
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Use of ESRT and ECAP in CI fitting including their utility in determining over- or under-stimulation
ESRT: * ESRT for predicting upper-stimulation levels * ESRT is within an average of 9 clinical units of upper-stimulation levels * Preferable methods for setting upper-stimulation levels in children as precise loudness scaling and balancing are often unreliable before age 8 * ESRT is lower than levels set by behavioral measures, making it a safer starting point ECAP: ART (MED-EL), NRI (AB), and NRT (Cochlear) * The ECAP represents a synchronous response from electrically stimulated auditory nerve fibers. (ECochg) * A neural response from the distal cochlear nerve fibers and/or spiral ganglion cell bodies of the cochlear nerve. * Typically recorded by stimulation of pulses applied to a single electrode at a relatively slow rate * ECAP give you upper and low levels
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Threshold needs to be at or below your ___ but you are never above
Threshold needs to be at or below your **ESRT** but you are never above
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Strategies for managing facial nerve stimulation
Facial nerve stimulation is common non-auditory stimulation point * 1st, Try l**owering the amplitude** - the current leak will become less. Drop it until you do not see the facial nerve stimulation anymore. * 2nd, **Increase the pulse width** if the amplitude is not loud enough, this gives the stimulation of more loudness. * 3rd, If they still cannot hear it, and the problem cannot be fixed by the other two ways, you can **turn off the electrode.**
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Indicators that the map is optimized and the patient is ready to transition to the maintenance phase
SF thresholds better than 30 dB. 10 hours+/ day with datalogs. Post-operative CNC word score in the implanted ear is 56% or better; OR. the patient’s scores in the implanted ear have improved by at least 20% when compared to scores obtained in that ear prior to implantation
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Typical Dyanmic range for CI programming
Default IDR 40 to 60 dB.