Implant, Cochlear
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- PMA Number
- P970051
- Supplement Number
- S140
- 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
- June 20, 2016
- Date Received
- December 23, 2015
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the optional acoustic component amplifies low frequency sound, and sends it into the ear canal. The acoustic component is intended to provide access to these low frequency sounds for some Cochlear Nucleus implant recipients.The acoustic component is indicated for recipients of traditional Cochlear Nucleus implants with unaided air conduction thresholds less than or equal to 85 dB HL between 125 Hz and 2000 Hz following surgery. The acoustic component should only be used when behavioural audiometric thresholds can be obtained and the recipient can provide feedback regarding sound quality.Speech perception testing should be completed before and after fitting with the acoustic component to ensure that the recipient performs as well, if not better, with the acoustic component than without it.
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 |