Cochlear Baha 4 Sound Processor
510(k) K132278
Cochlear Baha 4 Sound Processor is a Class II device made by Cochlear Americas, cleared under FDA 510(k) K132278 on 26 Sep 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132278 | Date26 Sep 2013 | StatusActive |
Official records
- FDA 510(k) database K132278
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LXB
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3302
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K132278
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Baha 4 sound processor, Champagne blonde 93630 | 93630 / 93630 | 09321502026444 | — | No longer on the market |
| Baha 4 sound processor, Chestnut brown 93633 | 93633 / 93633 | 09321502026413 | — | No longer on the market |
| Baha 4 sound processor, Demo Brown 94230 | 94230 / 94230 | 09321502026390 | — | No longer on the market |
| Baha 4 sound processor, Ocean Blue 93634 | 93634 / 93634 | 09321502026406 | — | No longer on the market |
| Baha 4 sound processor, Slate grey 93632 | 93632 / 93632 | 09321502026420 | — | No longer on the market |
| Baha 4 sound processor, Soft black 93631 | 93631 / 93631 | 09321502026437 | — | No longer on the market |
| Baha 94223 | 94223 / 94223 | 09321502026383 | — | On the market |
| BAHA FITTING SOFTWARE 5 CD P803255CD | P803255CD | 09321502074117 | — | On the market |
| BAHA FITTING SOFTWARE 6 CD P1682914CD | P1682914CD | 09321502074124 | — | On the market |
Similar devices
Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).
- BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) by Entific Medical Systems, Inc.
- XOMED AUDIANT BONE CONDUCTOR by Xomed, Inc.
- Baha 92129 by Cochlear Bone Anchored Solutions AB
- ADHEAR User Kit, Dove Silver 38197 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- PONTO PRO by Oticon Medical AB
- ADHEAR System by Med-El Elektromedizinische Geraete GmbH
- MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR by Xomed, Inc.
- PONTO PRO POWER by Oticon Medical AB
- TRANSEAR BONE CONDUCTION HEARING AID by United Hearing Systems, Inc.
- NOBELPHARMA BONE ANCHORED HEARING AID by Nobelpharma USA, Inc.