Cochlear Baha Implant System
510(k) K121317
Cochlear Baha Implant System is a Class II device made by Cochlear Americas, cleared under FDA 510(k) K121317 on 12 Oct 2012, 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 | NumberK121317 | Date12 Oct 2012 | StatusActive |
Official records
- FDA 510(k) database K121317
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAH
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3302
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K121317
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 93329 | 93329 / 93329 | 09321502022699 | Length 6 mm | On the market |
| Baha 93330 | 93330 / 93330 | 09321502022705 | Length 8 mm | On the market |
| Baha 93331 | 93331 / 93331 | 09321502022712 | Length 12 mm | On the market |
| Baha 93332 | 93332 / 93332 | 09321502022729 | Length 14 mm | On the market |
| Baha 93333 | 93333 / 93333 | 09321502022736 | Length 6 mm | On the market |
| Baha 93334 | 93334 / 93334 | 09321502022743 | Length 8 mm | On the market |
| Baha 93335 | 93335 / 93335 | 09321502022750 | Length 10 mm | On the market |
| Baha 93336 | 93336 / 93336 | 09321502022767 | Length 12 mm | On the market |
| Baha 93357 | 93357 / 93357 | 09321502033435 | Length 12 mm | On the market |
| Baha 93550 | 93550 / 93550 | 09321502025294 | — | On the market |
Similar devices
Other devices filed under FDA product code MAH (Hearing Aid, Bone Conduction, Implanted).
- BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE by Nobelpharma USA, Inc.
- Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm by Oticon Medical AB
- Ponto Bone Anchored Hearing System by Oticon Medical AB
- Healing cap with plug 30 mm 95084 by Cochlear Bone Anchored Solutions AB
- BAHA CORDELLE II by Cochlear Bone Anchored Systems AB
- Baha 95083 by Cochlear Bone Anchored Solutions AB