Cochlear Implants Midterm Flashcards
(75 cards)
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.
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
Who is considered the father of the cochlear implant?
William House
* spear headed the advancements in CI tech
Dr. Graeme Clark
* Motivated to develop bionic ear due to his fathers deafness
When did Dr.Graeme Clark implant his first patient?
1978 - implanted his first 3 PT’s
* mid 60’s is when he first started developing it
Why is Bilger’s report considered a landmark in the development of the cochlear implant?
- He evaluted early CI the results = the CI improved quality of life for all subjects
- lip reading & speech productions score were signifcantly better
What are the three major manufactures of CI?
Cochlear Nucleus
Advanced Biontics
MED-EL
What CI company has the first FDA approved multichannel device?
Cochlear Nucleus
Cochlear Nucleus has how many channels?
22 channels available for stimulation
Which FDA center is responsible for overseeing cochlear implant devices?
Center of Devices and Radiolgical Health
* CDRH regulates all companies that manufacture or import devices in the US
What are the different classes of medical devices?
Class I
* Devices pose the least amount of risk to PT = least amount of regulatory control
Class II
* Devices pose a moderate safety risk to PT = higher regulatory contol to “provide reasonable assurance of the device’s safety and effectivness
* Requires PMA
Class III
* Highest potential risk to the PT = highest level of regulatory contol
* Requires PMA
* Cochlear Implants
What class of medical devices do cochlear implant devices fall under?
Class III
What is premarket approval (PMA
PMA is a 4 step process
1. Adminstrative & limited review by FDA to determine completeness (acceptance & filling)
2. indepth scientific, regulartory & quality review by FDA (substantive review)
3. Review and Reccomendations by advisory committe (panel review)
4. Final Deliberations, documentaion & notification of FDA decision
what are some examples of changes that require the manufacturer to submit a PMA supplement?
- New indication for use of the device
- Labeling changes
- Changes in manufacturing facilities, methods, or quality control procedures
- Changes in sterilization procedures and packaging
- Changes in the performance or design specifications, circuits, components, ingredients, principles of operation, or physical layout of the device
What does PMA stand for?
Premarket approval
Examples of Changes that require a PMA supplement
- new indication for use of the device
- Lableing changes
- Change in manifacturing facilities, methods or quality control procedures
- Changes in sterilization procedures and packaging
- Changes in the performance or design specification, circuits, components, ingredients, principles of operation or physical layout of the device.
Who is responsible for designating the indications for cochlear implantation?
Colletive Teamwork of a multi-disciplinary group
* PT’s & family
* CI surgeon
* Audiologists
* SLP
* Deaf Educator
* Radiologists
Who is responsible for designating the audiologic criteria: who decides for cochlear implantation?
FDA doesnt set CI candidacy. Each manufacture submit a PMA app outlining indications for their device for FDA to approve or reject
* Approved = manufacturer-defined indications become the FDA criteria for device use = FDA labeled indications or FDA candidacy criteria
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.
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
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.
What are the FDA approved indications for traditional CI candidacy for Cochlear
- 18 +
- Bilateral SNHL
- Moderate to profound
- limited benefit from HA ampification
- < 50% in poorer ear and <60% in opposite eat for sentence recognition.
What are the FDA approved indications for traditional CI candidacy for Advanced Bionics
- 18 +
- Severe to profound SNHL >70 db
- limited benfit from HA’s 50% or less on test of open set sentences
What are the FDA approved indications for traditional CI candidacy for MED-EL
- 18 +
- Bilateral Moderate to profound SNH
- Limited benefit from HA’s
- 50% or less in implanted ear and 60^ pr less in non implant ear.
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
