Baha 5 Sound Processor
510(k) K142907
Baha 5 Sound Processor is a Class II device made by Cochlear Americas, cleared under FDA 510(k) K142907 on 25 Mar 2015, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142907 | Date25 Mar 2015 | StatusActive |
Official records
- FDA 510(k) database K142907
Recalls
-
- Terminated Z-0792-2020
Product was packaged with the Incorrect tamper proof battery door.
Timeline
- Cleared FDA 510(k) K142907
- Recall initiated FDA recalls Z-0792-2020
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- Withdrawn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 K142907
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 Battery Door, 10pcs 95330 | 95330 / 95330 | 09321502033220 | On the market | |
| Baha 5 Demo, Black 95207 | 95207 / 95207 | 09321502028721 | On the market | |
| Baha 5 Inner Case 95224 | 95224 / 95224 | 09321502032803 | On the market | |
| Baha 5 Sound Processor Battery door 3 Pcs P740869 | P740869 / P740869 | 09321502034272 | On the market | |
| Baha 5 Sound Processor Tamper-proof battery door 3 pcs P1129017 | P1129017 / P1129017 | 09321502041096 | On the market | |
| Baha 5 Sound Processor Tamper-proof battery door 95331 | 95331 / 95331 | 09321502033237 | On the market | |
| Baha 5 Sound Processor, Black 95202 | 95202 / 95202 | 09321502028776 | On the market | |
| Baha 5 Sound Processor, Blonde 95201 | 95201 / 95201 | 09321502028783 | On the market | |
| Baha 5 Sound Processor, Brown 95204 | 95204 / 95204 | 09321502028752 | On the market | |
| Baha 5 Sound Processor, Copper 95205 | 95205 / 95205 | 09321502028745 | On the market | |
| Baha 5 Sound Processor, Silver 95203 | 95203 / 95203 | 09321502028769 | On the market | |
| Baha 95448 | 95448 / 95448 | 09321502034159 | No longer on the market | |
| Baha P736025 | P736025 / P736025 | 09321502034180 | No longer on the market | |
| Baha Programming Cable Long Blue 91913 | 91913 / 91913 | 09321502016704 | On the market | |
| Baha Programming Cable Long Red 91914 | 91914 / 91914 | 09321502016711 | On the market | |
| Baha Programming Cable Short Blue 91911 | 91911 / 91911 | 09321502016681 | On the market | |
| Baha Programming Cable Short Red 91912 | 91912 / 91912 | 09321502016698 | On the market |
Similar devices
Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).
- Audiant Bone Conductor at The Ear Sound Pro by Xomed, Inc.
- Viennatone AN, Viennatone AS Fidelity F228, Fidelity F229 by Starkey Laboratories Inc.
- Second Ear Bone Conduction Hearing Aid by Wordcomp International Communication Group (Wicg)
- ADHEAR Professional Kit 38199 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Headband for BAHA by Entific Medical Systems, Inc.
- SoundBite Hearing System by Sonitus Medical, Inc.
- Ponto Plus and Ponto Plus Power by Oticon Medical AB
- Baha SoundArc Hair Matching Colour Kit P1572994 by Cochlear
- OTOMAG BONE CONDUCATION HEARING SYSTEM by Sophono, Inc.
- Baha 92128 by Cochlear Bone Anchored Solutions AB