Baha Intenso
510(k) K081606
Baha Intenso is a Class II device made by Cochlear Americas, cleared under FDA 510(k) K081606 on 28 Aug 2008, 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 | NumberK081606 | Date28 Aug 2008 | StatusActive |
Official records
- FDA 510(k) database K081606
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- Withdrawn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 K081606
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 90909 | 90909 / 90909 | 09321502040266 | — | On the market |
Similar devices
Other devices filed under FDA product code LXB (Hearing Aid, Bone Conduction).
- OTOMAG BONE CONDUCTION HEARING SYSTEM by Sophono, Inc.
- Bone conduction Hearing Aid (BM100) by Shokz Health Global Limited
- Ponto 3, Ponto 3 Power and Ponto 3 SuperPower by Oticon Medical AB
- Baha 93363 by Cochlear Bone Anchored Solutions AB
- Bone Conduction Hearing Aid (XTS-AISW-D1) by SHENZEN MAGNET TECHNOLOGY CO.,LTD
- Baha 92141 by Cochlear Bone Anchored Solutions AB
- ADHEAR Adhesive Adapters, beige, 15 pcs. 34689 by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Sophono Bone Conduction Systems (S) Configuration and (M) Configuration by Sophono, Inc.
- Baha SoundArc Medium P807176 by Cochlear
- Bone Conduction Hearing Aid (G41157) by ZDEER TECHNOLOGY (HENAN) CO., LTD