Midterm Study Guide Flashcards
(167 cards)
1
Q
Acoustic to acoustic
A
Conventional HAs
2
Q
Acoustic to mechanical vibration
A
takes acoustic energy, converts to electrical, then converts to mechanical energy to set something into motion
Middle Ear Implant (MEI)
Bone Conduction Hearing Devices (bone transmission)
3
Q
acoustic to electric
A
takes acoustic energy, converts to electrical, stays electrical to stimulate the auditory nerve
Cochlear implant
BS implant
4
Q
what is a middle ear implant
A
A surgically implanted component coupled to a structure in the ME that mechanically oscillates to facilitate stimulation of the cochlea
Causes the ossicles to vibrate → why it is mechanical
5
Q
why did MEI become a thought
A
Limitations of conventional hearing aids
Discomfort, social stigma, feedback, occlusion, insufficient gain, distortion
6
Q
what was the first MEI receiving FDA approval for commercial use and when
A
2000
Symphonix Vibrant Soundbridge
7
Q
parts of Symphonix Vibrant Soundbridge
A
External sound processor → mic captured sound, processed to digital signal to be transmitted to external coil through electromagnetic induction
Internal coil → processed the signal and delivered it to a vibrating mechanical component coupled to the ossicular chain
8
Q
What are the theoretical advantages of middle ear implants, and which of these remain applicable today?
A
Greater gain → still some feedback risk due to enhanced mechanical oscillation
Partially still applicable; there is still a risk for mechanical feedback
Avoidance of the OE → nothing in the ear canals
Crucial for those with external otitis or skin allergies
Unaffected by cerumen issues
*some MEI requires component in the EAC
Improved comfort → nothing in or on top of the ears
Especially those that are fully implanted
Higher-fidelity sound → less distortion because you don’t have to use as much gain due to the mechanical movement of the ossicles
Partially applicable: PT dependent, not guaranteed
depends on the PT, HA’s are high quality now and some are just as good to PTs
Aesthetic appeal → more discreet, especially when completely implanted
Continuous wear → fully implanted leads to 24/7 wear for daily activities including sleeping, showering, etc. with minimal feedback risk
9
Q
What are the theoretical disadvantages of middle ear implants?
A
Surgery → costly, requires few hours, risk of FN injury & infection, healing time needed before activation
Cost and insurance → more expensive than traditional HAs, not covered by ins, OOP expenses for services (16-30,000 per ear)
Why is it not covered?
Because we have HA’s that do the same things
Hearing implications → some need disarticulation of the chain which results in a max CHL so when device is off they will not hear as well as they did before because of that
MRI compatible → only MED-EL Vibrant Soundbridge (MRI up to 1.5 tesla)
Others contain magnets that prohibit an MRI unless removed
Verification challenges → MEI doesn’t produce acoustic output in the canal so REM measurements are not able to be done to verify gain/output settings
10
Q
What are the FDA-approved indications for middle ear implants, and how is candidacy assessed?
A
Ages 18+, moderate to moderately severe SNHL w/ >60% open-set word rec in optimal conditions, HL stable, normal ME anatomy & function (no infections), & experince w/ HA’s
11
Q
Those <60% might not experience improvement in hearing performance with MEI
A
true
12
Q
should you get MEI for mild HL?
A
no
13
Q
should you get MEI for severe to profound?
A
no there are CIs
not good enough to give that much amplification for that much of damage in the cochlea
14
Q
why does HL need to be stable for MEI?
A
if it gets worse they are CI candidates instead
15
Q
example of off label use of MEI
A
doesn’t fall within the indications of the FDA for these devices; agreed w/ PT and surgeon
could be offered to PT with mild loss and they insist for cosmetic and lifestyle reasons and provides ME implants
do not meet criteria but surgeon feels they fit for other reasons
16
Q
can you use MEI for CHL
A
can use if they do not have chronic MEO and the anatomy is preserved in order to attach the devices
17
Q
Why are MEI not as evident today?
A
Advances in digital HA tech has led to satisfactory hearing performance for most PTs w/ mild to severe SNHL
HA are cheaper, discrete, open fitting (OE avoided) and many options
Advances in CI and hybrid tech (along with expanded criteria) allows for those unable to achieve satisfactory performance w/ conventional HAs to consider CI as an alternative
18
Q
When & why would they still be used?
A
Fit → discomfort, otitis external, OE, poor retention, excessive cerumen
Use → limited vision, dexterity issues
Lifestyle → able to wear for sleep, swimming, heavy perspiration and athletic endeavors
19
Q
what does the audiological assessment consist of
A
Air & bone (octave & inter) → 250-8000 Hz
Mod to mod sev & no abg >10dB
Tymps & reflexes & wideband
Evaluate ME fxn
HA trial → see if they help first before doing surgery
REM → make sure they match Rx targets and are properly fit
Aided WRS
Everyday listening levels: 60-65dB SPL
Medical eval
CT scan → checks anatomy
MRI to avoid complications in surgery like CNS
Activation & monitoring
Few weeks after surgery
Conduct otoscopy to ensure no inflammation or discomfort
Programming → uses proprietary software & tools provided by manufacturer
Verification
No standards
Relies on behavioral & functional assessments to ensure they have benefit
SF detection w/ warble tones
Aided monosyllabic WRS in SF at 60 dBA
SIN
Standardized questionnaires (APHAB, COSI)
20
Q
What are the three types of transducers used in middle ear implants
A
piezoelectric
electromagnetic
electromechanical
21
Q
how do piezoelectric transducers work
A
Two key behaviors of the material
Apply electricity to material = vibrations/oscillations
Physically pressing it down or deforming it = generates electrical voltage
When the sound causes this material to vibrate it turns those vibrations into an electrical signal for processing
Electrical output matches the original input
If a sound wave hits the material with a certain frequency and loudness (intensity), the electrical signal it produces will mirror those characteristics
22
Q
adv to piezo
A
No external power source (crystals create the voltage within the device once the ™ moves
Robust stability & durability
23
Q
disadv to piezo
A
May not have enough amp for those with mod to severe HL due to limited output & narrow bandwidth
24
Q
what is the electromagnetic transducer
A
Used in current devices today
Has a biocompatible magnet attached ot the ossicular chain/ME structure & has a wired coil that is close to the magnet
magnet is attached to one of the middle ear bones (like the incus), and a small wire coil is placed near it
When electricity flows through the coil, it creates a changing magnetic field. This makes the magnet vibrate, which moves the middle ear bones to mimic sound vibrations
The speed (frequency) and strength (intensity) of the magnet’s movement match the pattern of the electrical signal—so it replicates the original sound accurately
25
what is the disadvantage to electromagnetic
Output is dependent on magnet-coil proximity
distance is going to change and as it changes it effets strength and output of the device from chewing and moving etc.
26
what is the elctromechanical transducer
Variant of electromagnetic and designed to eliminate the limitation with distance between coil and magnet it electromagnetic
if the coil and magnet are too far apart (or shift position), the system becomes less effective, so, the magnet and coil are built into a single, stable unit to keep their spacing consistent
This fixed setup ensures that mechanical energy (vibrations) is transferred efficiently and consistently to whatever it's attached to, like the ossicles or a prosthetic part of the middle ear
27
advantages to electromechanical
Delivers higher output levels and wider frequency responses
Not affected by variable output due to the magnet-coil distance
28
disadvantages to electromechanical
More complex
More prone to mechanical issues - if there is something wrong then the whole piece has to be removed compared to just the magnet or coil in the other design
29
What middle ear implant devices are currently available
Med-El Vibrant Soundbridge
Maxum (Ototronix, LLC)
Envoy Esteem
30
Whatis the vibrant soundbridge, what are their FDA-approved indications and components, and how do they work?
First MEI w/ FDA approval in 2000
Used to treat SNHL and performance varies with HL type
How it works
Sound is captured by external mics and analyzed by external processor
Signal is transmitted through electromagnetic induction to the VORP coil
The internal processor analyzes the signal and sends it down a lead wire to the floating mass transducer (FMT)
The FMT is an electromechanical transducer and converts electrical signal into mechanical vibrations that stimulate the ossicles and cochlea to mimic natural hearing
The current through the coil creates a magnetic field, oscillating the magnet within the FMT
18+, SNHL
AC thresholds with these ranges:
500 Hz → 30-65 dB
1 kHz → 40-75 dB
1.5 kHz → 45-80 dB
2 kHz → 45-80 dB
3 kHz → 50-85 dB
4 kHz → 50-85 dB
WRS → >/= 50% (recorded words) at 65 SPL or under earphones at MCL
Normal ME anatomy
Psychologically and motivationally suitable with realistic expectations of benefits & limitations of the device
*CHL would be off-label use
31
what are contraindications of the soundbridge
CHL
Retrocochlear of CAPD
Active ME infections
™ perfs with recurrent ME infections
skin/scalp condition that might preclude audio processor attachment
32
what is a transducer
energy converter (electrical → mechanical)
33
what is a vibroplasty
surgical attachment of FMT to the ossicles
34
what are the parts ot the soundbridge
Partially implantable w/ 2 components
External SAMA 2 audio processor
MED-EL Vibrant Soundbridge implant (Internal Vibrant Ossicular Prosthesis (VORP 502X))
35
Vibrant Ossicular Prosthesis (VORP 502X) Implant
electromechanical model
36
FMT Coupling Options in soundbridge
Long process of incus (for ossicular chain stimulation)
Body of incus
Round window (for direct cochlear stimulation in CHL/MHL)
37
drilled into the bones for stability
Fixation wings
38
What is the maxum (ototronix LLC), what are their FDA-approved indications and components, and how do they work?
How it works
IPC houses both the sound processor and the electromagnetic coil and receives sound, amplifies it and converts it to an electrical current to be delivered to the electromagnetic coil at the tip of the device
As the electrical current travels through the coil it is converted into an electromagnetic signal that emanates across the ™ & toward the maxum’s magnet that is coupled to the incudostapedial join at the neck of the stapes
This coil changes the sounds to electromagnetic signals to cause the implant to vibrate
FDA Indications
18+, moderate to severe SNHL, experience with appropriate fit HA’s, ABG /=60%
39
contraindications of the maxum
CHL
Retrocochlear or CAPD
Active ME infections
™ perfs with recurrent ME infecitons
Disabling tinnitus
40
what makes the surgery unique in the maxum
Unique feature → implanted under local anesthesia through the ™ (transcanal approach)
can be implanted in the surgeon’s clinic without the need for general anesthesia and without a mastoidectomy approach
As a result it is less invasive than those required for other MEI devices
41
What is the envoy system , what are their FDA-approved indications and components, and how do they work?
ONLY FDA approved fully implantable hearing device
The sound processor and battery are surgically placed in the bone behind the ear (temporal bone)
How it works
Sound enters the ear and makes the ™ and ossicles move
The sensor that is attached to the incus picks up this movement
A piezoelectric transducer creates electrical signals based off of the movement of the ™
Special material that makes electricity when moved
The electrical signal is sent to the sound processor which is analyzed and adjusted
This processed signal is sent to the driver that is attached to another ear bone
Driver has piezoelectric transducer that takes the electrical signal and creates vibrations
The vibrations move the stapes to send the sound into the IE just like in normal hearing
FDA Indications
18+, stable bilateral moderate to severe SNHL (based on PTA) and ABG /= 40% & preop WRS >/=60%
Normal ET function
Normal ME anatomy
Enough space for implant based on high rez CT scan
>/=30days of appropriately fit HAs
42
Given the envoy esteem is fully implantable, which type of transducer would this use?
piezoelectrical - because there is no external source
43
What is special about piezoelectrical materal or unique to it?
produce electricity through shaking and moving them - creates power or you can apply electricity they create vibrations
44
contraindications to the envoy esteem
Hx of post-adolescent chronic ME infections, IE disorders, or recurring vertigo needing treatmet
Mastoiditis, hydrops, meniere’s
Hx of fluctuating AC/BC HL over the last year of 15dB in either direction at 2 or more frequencies (from 500-4000)
Hx of otitis external or eczema of EAC
Cholesteatoma or destructive ME disease
retrocochlear/CAPD
Disabling tinnitus that requires treatment
Hx of keloid formation
Hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
Pre-existing medical condition or undergoing treatment that might affect healing process
Pregnant
45
disadvantages to the envoy esteem
Not MRI compatible (do not consider if individual needs serial MRI assessments)
Cost → 35-40,000 per ear and insurance doesn’t cover cost
46
when can the envoy be programmed
Typically activated around 6-8 wks post-op
Usually reaches full potential around 4-6 months post-surgery
47
what are the components of the envoy
All contained in one implantable device in the temporal bone
Sensory
Sound processor
Driver
Non-rechargeable lithium-iodide battery
48
where are the parts of the esteem
The sound processor and battery are surgically placed in the bone behind the ear (temporal bone)
Inside the middle ear, there are two key parts: a sensor and a driver
49
what is a bone conduction hearing device
a HA that amplifies sound through BC for those with issues in outer and middle ears
Transfers sound by bone vibration directly to the cochlea to bypass the outer and middle ear
It is fixed to the head with an elastic band or surgically implanted internal component
The external component captures background noise and makes its sound reach the cochlea through mechanical amplification
50
5 Pathways of BC Physiology
Sound radiation to EAC
ME ossicle inertia
Inertia of cochlear fluids (most likely this one)
Vibration sets the fluid in motion
Compresison of cochlear walls (IE compression)
Pressure transmission from CSF
51
What are the basic components of BAHA
External sound processor → captures acoustic signals, converts to mechanical vibrations and delivers these to the internal component
Titanium component → surgically implanted in the skull
Delivers mechanical vibrations to the cochlea through BC
52
what is the abutment
Sticks of of the skin
Sits on the titanium fixture that holds the implant and the sound processor is snapped onto this portion
53
what is the function of the electromagnetic transducer in BCD?
Job is to convert an electrical signal into mechanical vibrations that are used to stimulate the cochlea through BC
How it works
Two main parts: armature (moves) and the yoke (stays still)
Both are made of ferrite which is a magnetic-friendly ceramic material
The armature is surrounded by a coil and contains a permanent magnet
When the electrical current passes through the coil it creastes a magnetic field in the armature
As the current changes (in intensity & frequency) the magnetic field fluctuates making the armature move back and forth toward or away from the yoke
This movement = mechanical energy = vibrating the skull = vibrations traveling to the cochlea to perceive sound
Spring - suspension system that keeps the armature and yoke from coming into contact
54
What are the common complications associated with BAHA?
The skin is always open so regular cleaning is essential
Peri-implant infection
Flap necrosis
Loss of abutment (infection/trauma)
Osseointegration failure
Cosmetic factors
Skin numbness
Skin overgrowth
55
how does the electromagnetic transducer convert sound into mechnical energy
through oscillating magnetic fields that move an armature to create vibration
56
what is the holgers classification system
grades soft tissue reactions at the implant site
0 is good (reaction free skin)
4 - overt signs of infection requiring implant removal
57
if the transducer is within the speech processor
passive
58
if transducer is within the implant itself and closer to the bone
active
59
are non surgical passive or active?
passive becuase there is nothing inside
60
can surgical devices only be active
no can be either?
61
what is skin drive
Vibration is conducted through the skin
External device is placed on the skin's surface
No coupling
In tact skin
62
what is direct drive
Vibration is conducted through an implanted transducer
Skin is not intact
63
what is active
Vibration is directly applied to the bone (direct drive bone conduction)
Ideal BC sound transmission
Transducer is implanted
64
what is passive
Transducer is in the speech processor
Stimulation is applied outside onto the skin
Less ideal because skin attenuates the signal before it reaches the bone
65
what is percutaneous
Through the skin (penetrates it) - usually referred to as BAHA
Will see a fixture when removing the device
66
what is transcutaneous
Across the skin
Skin stays in tact
When you remove the device there is nothing there
67
what is osseointegration
Process which bone cells adhere to the surface of the implanted fixture itself
Formation of a natural bond between titanium and bone
68
Bone cells grow onto the titanium implant, forming a natural bond keeping the implant secure
Cannot remove implant without removing part of the bone
\
osseointegration
69
two broad categories of surgeries
Osseointegrated devices
Non-osseointegrated devices
70
Implants are attached to the bone of the skull but do not rely on ossseointegration for fxn of the device
non osseo
71
Implants require surgically placing an implant screw that integrates with the temporal bone
Bone of the implant site grows onto the implant skrew forming a biologic attachment
osseo
72
A titanium fixture is screwed into the bone and sticks out through the skin
percutaneous
73
Skin stays intact—nothing visible when device is off
Vibrations go through skin to reach the implant
transcutaneous
74
The implanted piece does the vibrating
active
75
The part that vibrates is in the external device
Stimulation is applied outside onto the skin
passive
76
which of the following best describes the process of osseointegration in BCDs
fusion of skin with metallic implant surface
adhesion of bone cells to surface of titanium fixture
creation of magnetic field to secure implant
mechanical coupling of bone with silicone implants
adhesion of bone cells to surface of titanium fixture
77
what is akey distinctino bw percutaneous and transcutaneous BCDs in terms of sound transmission
percutaneous uses a magnetic plate under the skin
transcutaneous transmits sound vibrations across intact skin
trnascutaneous allows direct screw connection to the abutment
percutaneous doesn't require osseointegration
transcutaneous transmits sound vibrations across intact skin
78
advantages & disadvantages to percutaneous
Advantages
MRI approved up to 3T
Direct transmission results in lower thresholds (5-10dB at 1&2 and 10-25dB at 4-8)
Good for those with skin sensitivity
Disadvantages
More risk of complications
More wound care
More difficult to remove and attach - especially for those with dexterity concerns
79
advantages and disadvantages to transcutaneous
Advantages
Lower rate of complications
Minimal wound care
Easier attachment & removal
Disadvantages
Only MRI approved up to 1.5T
Skin attenuation up to 20dB (especially HFs)
Magnet pressure can cause scalp soft tissue issues
80
indications for transcutaneous
5+yrs w/ skull thickness 2.5mm and skin thickness 3mm
BC 45dB or better
Good for CHL or SSD w/ normal BC in better ear
81
indications for percutaneous
5+yrs, skull thickness 2.5mm
CHL w/ no HA benefit
MHL w/ mild-moderate SNHL w/ BC 65dB or better(averaged at 5, 1, 2, & 3)
SSD
Better ear BC better or equal to 20dB (some in mild range can have benefit)
82
what is the candidacy eval for BCD
AC for each ear from .25 to 8 kHz
BC at .25, .5, 1, 1.5, 2, 3, & 4 kHz (masking when needed)
Speech for each ear (understand benefits from BCDs but not a requirement for candidacy)
83
What are the candidacy criteria for bone conduction devices in patients with CHL & MHL
Calculate average BC thresholds
BC: .5, 1, 2 and 3 kHz
candidate if ≤ 65 dB HL
Additional consideration
Average ABG at .5, 1, 2, & 4 kHz
Candidate if >/= 30dB
Surgical age: 5+
Non-surgical: any
84
What are the candidacy criteria for bone conduction devices in patients with SSD
Poor ear
>/=80 dB (prodound SNHL)
Good Ear
AC PTA
85
What are the main benefits of using a bone conduction device for patients with SSD?
They alleviate the head shadow effect to improve speech rec in quiet & noise when speech arrives from the side of the poorer ear
86
during listening tests for SSD how should the speech and noise be routed
speech to the poorer ear and noise ot the better ear
87
what specific feature of BI300 fixture in BAHA Conect system enhances rapid osseointegration
tioblast surface to promote osteoblast migration
88
how does oticon's optigrip geometry enhance performance of ponto implant system
increases surface area for bone adherence
89
is cochlear baha passive or active? percu or transcu?
passive (stim outside on the skin)
percutaneous (skin is not in tact)
osseointegrated
partially implanted
90
is cochlear osia passive or active? percu or transcu?
active
transcutaneous
osseointegrated
partially implanted
91
is Oticon Ponto passive or active? percu or transcu?
passive
percutaneous
osseointegrated
partially implanted
92
is Med-El Bonebridge passive or active? percu or transcu?
active
transcutaneous
partially implanted
93
Medtronic Sophono passive or active? percu or transcu?
passive
transcutaneous
osseointegrated
partially implanted
94
What nonsurgical bone conduction options are available to patients?
Med-El ADHEAR
Stick, click, hear
Doesn’t exert any pressure on the skin
Has an adhesive adapter that is a soft sicky pad that has a plastic connector to couple to the processor and placed on a hairless area behind the auricle
Delivers the mechanical oscillations to the mastoid bone
glasses
BAHA 5 Softband & SoundArc
95
what do you need for BC candidacy?
average BC thresholds
just need the audio
96
why do we do the demonstration (formal listening something)
doing it to demonstrate to PT to see what it feels like to hear through these devices and the improvements theyll receive
not for candidacy
97
limitations to non-surgical BC options
Soft tissue attenuation
Chronic pressure from device
98
Who is considered the father of the cochlear implant?
William F. House
99
Why is Bilger’s report considered a landmark in the development of the cochlear implant?
Results showed CI improved quality of life for all study subjects
Lip-reading & speech production scores were significantly better with the implant activated than without it
100
Which FDA center is responsible for overseeing cochlear implant devices?
Center of Devices and Radiological Health (CDRH)
Office of Device Evaluation (ODE) - approves class III devices (CIs)
Office of Compliance (OC) - reviews & approves manufacturing and quality-control changes for class III devices
101
class I medical device
Pose least amount of risk to PT
Subject to least amount of regulatory controls
Examples: tongue depressors, floss, bandages, stethoscope, HAs, manual wheelchairs
102
class II medical devices
Moderate safety risk to PT
Subject to higher regulatory controls to provide reasonable assurance of the device’s safety and effectiveness
Examples: powered wheelchairs, xray machine, some bc devices, middle ear implants
103
class III medical devices
Poses highest potential risk to PT
Subject to highest level of regulatory control
Examples: pacemakers, ABIs, some BC devices, & CIs
104
class II & III does not need premarket approval (PMA) before they can offer it to PTs and put on the market
FALSE
105
What is premarket approval (PMA)
four-step FDA process involving scientific and regulatory review to ensure device safety and efficacy
Most stringent type of device marketing application required by the FDA
106
describe the PMA steps
Acceptance and Filing Reviews
FDA checks if PMA app is complete & organize looking for documents, signatures, paid fees, scientific data
Checks if the PMA is acceptable for a full review
Substantive review
Looks at clinical and non-clinical data, bench testing, statistical analysis, manufacturing processes and compliance with quality system regulations
Makes sure the device is safe, effective and manufactured in a high-quality way
Panel Review
Includes presentation from the company, discussions among scientists, clinicians & PT reps, and recommendations to FDA
Gets the experts input to support the FDA’s decision making
Final deliberations & decision
Reviewers and leadership meets to make the final decision
Approved - issue approval order with labeling, conditions for use, and post-market requirements
Denied - includes a detailed explanation
Officially notifies the sponsor of the FDA’s approval or denial of the PMA
107
what are some examples of changes that require the manufacturer to submit a PMA supplement
New indication for device usep
Labeling changes
Manufacturing facility/method changes
Changes in sterilization or packaging
Changes in device design, ingredients, circuits
Extending expiration date based on new testing
108
Who is responsible for designating the indications for cochlear implantation?
Manufacturers propose indications in their PMA applications; the FDA approves them. The FDA does not set the indications
109
What is the difference between “labeled” and “off-label” indications, and when would each be considered?
Labeled: Indications approved by the FDA and listed in the manufacturer's labeling
Off-label: Use outside of FDA-approved indications, allowed if based on sound scientific evidence and properly documented
SSD for example in AB - only have label for bilateral
3 conditions to meet by physicians
Be well informed about the produce
Base use on firm scientific rationale and sound medical evidence
Maintain records of product’s use and effects
110
FDA-Approved Indications for traditional CI candidates
18+
Moderate to profound HL in LF (250-1000 - AB) and profound HL (>90dB HL) in mid to HFs in BOTH ears
Limited amp benefit: preoperative test scores of ≤ 50% sentence recognition in the ear to be implanted and ≤60% in the opposite ear or binaurally
111
FDA-approved indications for traditional cochlear implant candidacy in adults for Advanced Bionics
18+
-Bilateral Sev to Profound SNHL (≥70 dB HL)
-Limited amp benefit (≤50% sentence recognition in the ear to be implanted (HINT-open set)
112
FDA-approved indications for traditional cochlear implant candidacy in adults for cochlear
18+
-LF: bilateral mod to profound SNHL (≥40 dB HL) & mid-HF: sev to profound SNHL(≥2kHz; ≥70-90 dB HL)
-Limited amp benefit (≤50% sentence recognition in the ear to be implanted and ≤60% in contra ear or binaurally)
113
3 conditions to meet by physicians
for off label use
Be well informed about the produce
Base use on firm scientific rationale and sound medical evidence
Maintain records of product’s use and effects
114
FDA-approved indications for traditional cochlear implant candidacy in adults for MED-EL
-18+
-Bilateral moderate to profound SNHL ≥70 dB HL
-limited speech understanding (≤40% open-set sentence recognition in the best-aided condition)
-≤50% CNC words in implant ear; ≤60% in non-implant ear
115
FDA-approved indications for traditional cochlear implant candidacy in children for MED-EL
-1yr+
-bilateral profound SNHL w/ >90dB at 1kHz
-limited amp benefit (lack of developmental progression over 3-6mos period for younger and older <20% correct on MLNT or LNT)
-3-6mos HA trial required
116
FDA-approved indications for traditional cochlear implant candidacy in children for cochlear
-9-24mos: bilateral profound SNHL, limited amp benefit binaurally
-2-17yrs; bilateral sev to profound SNHL, limited amp benefit (MLNT or LNT scores ≤30%)
117
FDA-approved indications for traditional cochlear implant candidacy in children for AB
-12mos-17yrs
-Bilateral Sev to Profound SNHL (≥70 dB HL)
-Limited amp benefit (≤12% on difficult open-set word rec tests & <30% on open-set sentences
118
What are the candidacy criteria Cochlear Hybrid
18+
normal to moderate HL in LFs (better than 60 dB) and sev/profound in mid to HFs (>/=75dB) in implant ear and moderately sev to profound in mid to HFs (>/=60dB) in contra ear
Aided CNC bw 10-60% in poor ear (implant ear) with better ear better than implant score but no better than 80% correct
119
What are the candidacy criteria forMED-EL EAS
≤65 dB HL up to 500 Hz, ≥70 dB HL above 2kHz, CNC score ≤60% at 65dB SPL in best aided condition & no ABG >15dB
120
What are the candidacy criteria forSSD
5+
Profound SNHL in one ear & normal/near normal in contra ear
Limited benefit from appropriately fit unilateral HA:
121
What are the candidacy criteria for AHL
≥15 dB PTA difference
Severe to profound SNHL in one ear and mild-mod in contra ear
122
SSD criteria in adults
Limited uni HA benefit: <5% on CNC in poor ear?
*Med-El & Cochlear are FDA approved & AB has CE mark to use in Europe but not approved in US
123
SSD criteria in children
Limited uni HA benefit: aided speech <5% in poor ear & trial CROS for 1 mo before implant
124
which cochlear implant manufacturer is not fda approved for SSD
MED EL first to receive it
cochlear hybrid is expanded for SSD in 5+
AB has CE mark in Europe
125
What are the current Medicare eligibility criteria for cochlear implant coverage?
Bilateral moderate-to-profound SNHL with limited benefit from amplification (≤60% open-set sentence scores), freedom from middle ear infections, accessible cochlear lumen, and no central lesions and follow FDA approved labeling
126
Under what circumstances would the hearing aid trial period be waived for children?
If radiologic evidence of cochlear ossification (post-meningitis, etc.) is present, the trial can be shortened or waived
127
What is the minimum and maximum age approved by the FDA for cochlear implantation?
9 mos (cochlear devices)
No max age: any adults can be implanted if they meet the criteria
128
Why is it important to image the auditory anatomy with CT and/or MRI prior to implantation?
To confirm:
Insertion feasibility for the electrode array
Presence and condition of the auditory nerve
Aplesia: n is completely missing
Hypoplesia: underdeveloped n
Best ear for implantation
129
What are some absolute (not relative) contraindications for cochlear implantation?
Absent cochlea or cochlear nerve
Neurological damage to the auditory processing areas
Damaged auditory cortex
Medical risks that outweigh the benefits
130
When unilateral implantation is considered, what factors are used to determine which ear should be implanted?
Anatomy and nerve status
Degree of residual hearing
Occupation
Previous HA benefit
Surgical considerations (FN proximity)
131
What are the factors known to affect cochlear implant outcomes, and how do they influence performance?
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
132
What are the 60/60 guidelines, and how do they help address the under-referral of cochlear implant candidates?
When to refer for a CI eval
Better ear unaided monosyllabic word score ≤ 60% correct
Better ear unaided PTA ≥ 60 dB HL (PTA of .5, 1, & 2kHz)
Purpose: Helps clinicians identify and refer potential CI candidates earlier, addressing the problem of under-referral
133
Why is it important to include 125 Hz when evaluating CI candidacy?
It shows us more information about their residual hearing
helps assess potential for hearing preservation and guides postoperative amplification strategies
Present post op = better outcomes
Helps counsel through expectations about potential HL
134
According to MSTB-3, what are the four key steps in the cochlear implant candidacy assessment process recommended for best clinical practice?
Comprehensive audiologic evaluation: otoscopy, immittance, AC (octave & interoctaves including 125)
Hearing aid verification: REM to verify Rx are matched (65SPL), listening check, & electroacoustic check for noise/distortion; if HA’s are insufficient provide loaner’s that are properly fit
Aided speech recognition testing: Minimum Speech Test Batter (MSTB); CNC & AzBIO (RE only, LE only & bilateral if needed)
Outcome measures (e.g., patient questionnaires & fxnal measures)
135
What is the purpose of a hearing aid evaluation prior to beginning aided speech assessment?
Ensure hearing aids are optimally fitted to maximize aided speech recognition and rule out issues like internal noise or distortion
If they are not provide loaners that are properly fit & programmed for accurate aided results for candidacy measures
136
What is the purpose of calibration prior to aided speech assessment?
ensures that speech stimuli are presented at consistent, clinically accurate levels, avoiding misclassification of CI candidacy
137
Input calibration:
1kHz pure tone to Ext A & Ext B using VU meter to read around 0; prevents distortion/clipping of input signal
138
output calibration
SLM with mic 1m from loudspeaker at head height w/ a-weighting and fast responses; ensures speech is presented at dB you are intending
SHOULD BE USING A SPEECH SHAPED CALIBRATION SIGNAL (speech noise)- ON COMPS
Adjust audio by 1dB until reaching desired level
139
How should the test booth be set up for traditional candidates
SF
Front-facing speaker w/ calibrated levels
Fxnal gain: SF w/ warble tones
Unaided & aided CNC presented @ 60dBA in SF @ 0◦ azimuth
Unaided & aided adaptive SIN tests @65dBA (Quick-SIN, BKB-SIN)
Signal at 0 & noise 180
140
How should the test booth be set up for SSD
Isolate TE with plug & muff, masking noise, or insert & circumaurals
Fxnal gain: SF w/ warble tones
Unaided & aided CNC presented @ 60 dBA in SF @ 0◦ azimuth
Unaided & aided adaptive SIN tests @65dBA (Quick-SIN, BKB-SIN)
Signal at 90 (poor ear) & noise 270 (better ear)
Test Protocol:
Quiet - sentences at 60 dBA 0
Noise -
Sentences at 65 dBA 0 & babble at 270 at 55dBA for +10SNR, 60dBA for +5SNR
141
What are the main speech tests used in the MSTB-3 battery?
CNC monosyllabic word test: primary measure for clinical candidacy
Get each aided ear separately
Contra ear should have insert w/ noise to isolate TE
Candidate: ≤60% (move straight into AzBIO) in TC/EAS
≤5% in SSD/AHL
AzBIO Sentences in quiet and/or noise: insurance clinical candidacy requirement for coverage
142
Previously, AzBio sentences were used to determine implant candidacy. In the current MSTB-3, CNC word testing is the clinical basis for determining candidacy. What are the rationales for this change?
CNC tests provide a stricter, more objective measure of speech recognition ability
Open-set sentence tests (like AzBio) can inflate scores through contextual cues
143
What approaches are used to isolate the non-test ear (NTE)?
Plug & muff: acoustic sealing w/ no masking (use this for AzBIO)
Masking noise through inserts
Inserts & circum aurals together: acoustic sealing w/ masking
144
What are the MSTB preoperative CI candidacy protocols used to determine candidacy for traditional candidates/EAS
Best-aided CNC scores for candidacy in ear/s to be implanted
Test each ear individually
Present in SF at 60 dBA from front & administer 1 50 word list with masking in NTE
≤60% score move on to AzBIO (test R, L or bilateral if both are below 60)
Best-aided AzBIO sentences for ear/s to be implanted
Present in SF at 65 dBA in +10SNR with one list with plug&muff in NTE
To further evaluate insurance requirments: present at +5SNR or in quiet
Optional: not required for candidacy but good for post-op comparison
Everyday listening environment - both HA’s on and no plug&muff of NTE
Administer outcome assessments
CI-QOL10, SSQ-1 and/or THI
If meet clinic & insurer criteria: Medical Eval
Aided testing in each ear separately & bilaterally as needed
145
What are the MSTB preoperative CI candidacy protocols used to determine candidacy for SSD/AHL
Isolate TE (CRITICAL)
Best Aided CNC scores in ear to be implanted
Mask NTE to isolate TE to be implatned
Present in SF at 60 dBA from front & administer 1 50 word list
≤5% score move on to AzBIO
Best-aided AzBIO sentences for ear to be implanted
Present in SF at 65 dBA using 0SNR with one list
Signal to poor ear (TE/candidae ear) & noise to good ear (NTE/not candidate)
Plug and muff NTE
Optional
Everyday listening environment - both HA’s on and no plug&muff of NTE
AzBIO at 65dBA & 0SNR (signal to poor ear & noise to good ear
Questionnaires
Med Eval
146
What is the main purpose of postoperative CI assessment, and what are the components of this assessment?
Purpose: assesses functional benefit and tracks PT progress
Components
Unaided & aided audios
Speech testing (CNC & AzBio)
PT questionnaires (CIQOL-10, SSQ-12)
Bimodal benefit assessment
147
What is the recommended MSTB-3 follow-up schedule after implantation, and when should additional visits be considered within that timeline?
Post op testing at 3 mos and 12 mos following implantation
If testing not good at 3 mos consider more testing before 12 mos
148
what is the recommended MSTB-3 follow-up test batter after implantation
Unaided thresholds in implanted ear: BC & AC
Unaided thresholds for non-implanted ear
Aided SF thresholds of implanted ear
CI mapping optimization: aided SF thresholds bw 20-30dB across 250-6000 in adults
Aided speech assessment
CNC in implant ear at 60 dBA with 1 50 word list (isolate NTE)
Poor score = adjust programming
Test AzBIO in +10SNR
Optional
Everyday listening AzBIO (quiet or +5SNR)
?aires for perceived benefit and/or QOL
149
How are the benefits of bimodal hearing determined?
Compare AzBio scores at +10 SNR in CI-alone vs. CI + hearing aid (bimodal condition)
Improvement in scores with CI & HA = bimodal benefit
No improvement - consider non-implanted ear as potential CI candidate
150
How is ANSD diagnosed in children, and why is additional testing important for determining the site of lesion?
Tests
OAEs - present
Reflexes
ABR - presence of CM
Additional testing pinpoints whether the site of lesion is cochlear or neural, crucial for determining candidacy and prognosis
ASSR, CAER
151
Speech Materials for Kids
Ages 2–5 years (Closed-set tests):
Early Speech Perception (ESP)
NU-CHIPS
Mr. Potato Head test
152
Speech Materials for Kids older than 5 (open set)
Multisyllabic Lexical Neighborhood Test (MLNT)
Lexical Neighborhood Test (LNT)
Phonetically Balanced Kindergarten (PBK)
Consonant-Nucleus-Consonant (CNC)
153
What are some examples of parental questionnaires used to track postoperative development of auditory skills in children?
LittleEARS Auditory Questionnaire
0-2yrs
Parents' Evaluation of Aural/Oral Performance of Children (PEACH)
3-7yrs
Meaningful Auditory Integration Scale (MAIS)
3-5yrs
Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)
0-36mos
154
Pediatric Minimum Speech Test Battery (PMSTB)
≥ 75–80% →
Transition to a more advanced measure (in the same or next session)
155
Pediatric Minimum Speech Test Battery (PMSTB)
< 25% →
Use a simpler measure
156
Pediatric Minimum Speech Test Battery (PMSTB)
25–79% →
Indicates emerging skills; continue using the current measure
157
Pediatric AzBio
5yrs+ (2nd grade language level)
16 lists; 20 sentences each w/ female talker and ranges from 3-12 words in length
Scored same
Present in quiet (60 dBA) and in noise (65 dBA +5SNR)
158
moderate (250-1000) to profound in BOTH ears
tc
159
one ear normal/near normal and other severe to profound
ssd
160
HL in both sides with one severe to profound and the other elsewhere with HL (15dB gap or more bw ears)
AHL
161
what are the external compoents of CI
mic
speechprocessor
coil
antenna
magnet
power source
162
what does each external ci component do
1. Microphone - picks up acoustic signal and turns into electrical to be sent to the speech processor
2. Digital speech processor - converts microphone input or other input into patterns of electrical stimulation
3 & 4. coil/antenna - delivers electrical data; external transmitter delivers data to the internal receiver (antenna) through radio frequency
5. Magnet - locates and maintains connectivity bw internal and external parts
6. Power source - rechargeable or disposable batteries
163
what are internal implant parts
magnet
signal processor
stimulator
electrode lead
electrode array
164
what do each internal ci component do
Magnet - maintains connectivity with external hardware
receiving/transmitting coil (internal antenna) - receives data delivered by external transmitter through 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 electric current from the stimulator to the electrode array that is housed in the cochlea
Electrode array - stimulates the auditory nerve fibers in the cochlea
165
In general, how does a cochlear implant convert sound into electrical stimulation, step-by-step, from sound pickup to nerve stimulation?
Small mic behind the ear picks up the sounds
Mic turns acoustic info to electrical info and amplifies it and sends the sounds to speech processor that cleans up and converts it into digital signals
The digital signals are sent to the external transmitting coil on the outside of the head which sends the info and power by a radio frequency through the skin to the implant inside (internal receiver)
Internal receiver/stimulator decodes the digital signal and sends electrical impulses to the electrode array implanted in the cochlea
The electrodes stimulate the auditory nerve wiith controlled electrical impulses which the brain interprets as sound
Amplitude, duration and rate of these pulses are controlled by the speech processor
166
explain how a cochlear implant convert sound into electrical stimulation, step-by-step, from sound pickup to nerve stimulation for a PT
A cochlear implant helps you hear by turning sounds into electrical signals your brain can understand.
It starts with a tiny microphone behind your ear that picks up sounds and sends them to a small computer (the processor). That computer turns the sound into a special signal and sends it through a small coil on your head to the implant under your skin.
The implant then sends the signal to tiny wires inside your inner ear, which gently stimulate your hearing nerve. Your brain receives these signals and turns them into sound!
It doesn’t make your hearing "normal," but it can really help you understand speech and sounds better. It does take time and practice to get used to, and regular follow-up and listening therapy help you get the best results
167
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