Baha 5 Power Sound Processor
510(k) K161123
Baha 5 Power Sound Processor is a Class II device made by Cochlear Americas, cleared under FDA 510(k) K161123 on 20 May 2016, 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 | NumberK161123 | Date20 May 2016 | StatusActive |
Official records
- FDA 510(k) database K161123
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- Withdrawn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 K161123
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 5 Power Inner case 95980 | 95980 / 95980 | 09321502034661 | On the market | |
| Baha 5 Power, Black 95471 | 95471 / 95471 | 09321502034593 | On the market | |
| Baha 5 Power, Black Demo 95475 | 95475 / 95475 | 09321502034630 | On the market | |
| Baha 5 Power, Blonde 95470 | 95470 / 95470 | 09321502034586 | On the market | |
| Baha 5 Power, Brown 95473 | 95473 / 95473 | 09321502034616 | On the market | |
| Baha 5 Power, Copper 95474 | 95474 / 95474 | 09321502034623 | On the market | |
| Baha 5 Power, Silver 95472 | 95472 / 95472 | 09321502034609 | On the market | |
| Baha® Fitting Software 5 P1457850 | P1457850 / P1457850 | 09321502044097 | On the market | |
| Baha® Fitting Software 5.2 P878155 | P878155 / P878155 | 09321502038959 | No longer on the market | |
| Baha® Fitting Software 5.2 P878156 | P878156 / P878156 | 09321502038966 | On the market |
Similar devices
Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).
- Baha SoundArc Small P807175 by Cochlear
- ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. by Xomed, Inc.
- Baha SoundArc Extra Large P807178 by Cochlear
- OTOMAG BONE CONDUCTION HEARING SYSTEM by Sophono, Inc.
- ADHEAR Adhesive Adapters, brown, 15 pcs. 34690 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON by Audifon-USA, Inc.
- AUDIANT BONE CONDUCTOR OR A.B.C. by Xomed, Inc.
- BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. by Entific Medical Systems, Inc.
- BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) by Entific Medical Systems, Inc.
- Baha 92129 by Cochlear Bone Anchored Solutions AB