Implant, Auditory Brainstem
Basic Information
- Device Name
- Implant, Auditory Brainstem
- Trade Name
- NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT
- PMA Number
- P000015
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- MHE
- Generic Name
- Implant, auditory brainstem
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 13, 2016
- Date Received
- December 18, 2015
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the Nucleus ABI541 Auditory Brainstem Implant, a modification to the existing ABI24M device, which is intended to restore a level of auditory sensation via electrical stimulation of the cochlear nucleus in individuals 12 years of age or older who have been diagnosed with Neurofibromatosis Type 2 (NF2). Implantation may occur during first or second side tumor removal or in patients with previously removed acoustic tumors bilaterally. Because the surgical procedure for tumor excision and electrode placement eliminates residual hearing, preoperative audiological criteria are not relevant. This supplement also requested approval for a new bodyworn battery pack compatible with the Nucleus 6 Sound Processor, and the ability to program ABI541 recipients using the Advanced Combination Encoder (ACE) sound coding strategy.
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 |
|---|---|---|---|
| MHE | Implant, Auditory Brainstem | FDA class 3 | Unknown |