Implant, Cochlear
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- AUDALLION BEAMFORMER
- PMA Number
- P890027
- Supplement Number
- S046
- Device Class
- FDA Class 3
- Product Code
- MCM
- Generic Name
- Implant, cochlear
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 25, 1998
- Date Received
- September 21, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1) switch on/off circuit improvements, 2) replacement of the LC filter with an RC filter, 3) battery spring design change, and 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion. Regarding item 2), the RC filter will improve the rejection of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available processor settings on the Audallion, enabling the device to be more user friendly.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCM | Implant, Cochlear | FDA class 3 | Unknown |