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Sign in to claim this brandCochlear Bone Anchored Solutions AB
US
Last updated May 24, 2026
What Cochlear Bone Anchored Solutions AB makes
The company manufactures bone-conduction hearing implant systems, including sound processors and vibrators like the Baha series, as well as softbands for unilateral use. It produces craniofacial bone screws that are non-bioabsorbable and orthopaedic fixation system implantation kits, both reusable and single-use. Surgical tools such as screwdrivers and power tool control units are also part of its portfolio, alongside audiometric and hearing device software for wireless-fitting and programming purposes.
These devices are regulated under FDA’s classification system as either Class I or Class II, with relevant products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, adhering to applicable U.S. regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- cochlear.com
- —
- —
- [email protected]
- Phone
- +1(800)523-5798
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 559784736
Catalogue (367)
Page 7 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baha | 90446 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Mint | P2054769 | FDA UDI | Class II | Active |
| Cochlear™ Baha® 6 Max Sound Processor, Black, 2mm | P1809178 | FDA UDI | Class II | Active |
| Cochlear Baha SounBand bilateral, Blonde | P1827074 | FDA UDI | Class II | Active |
| Guide Pin 10 mm | 90794 | FDA UDI | Class II | Active |
| ISO Adapter for Multi wrench | 92347 | FDA UDI | Class I | Active |
| Baha | 92138 | FDA UDI | Class II | Active |
| Baha Softband bilateral, Red | 95766 | FDA UDI | Class II | Active |
| Baha | 92832 | FDA UDI | Class II | Active |
| Baha | 92834 | FDA UDI | Class II | Active |
| Baha | 92128 | FDA UDI | Class II | Active |
| Baha | 90909 | FDA UDI | Class II | Active |
| Baha | 91054 | FDA UDI | Class I | Active |
| Baha | 92843 | FDA UDI | Class II | Unknown |
| Baha 7 Sound Processor, Brown | P2054747 | FDA UDI | Class II | Active |
| Gold bar Ø2 x 100 mm | 90448 | FDA UDI | Class II | Active |
| Baha | 92141 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook+ (Large, Mocha) | P771906 | FDA UDI | Class II | Active |
| Baha | 90800 | FDA UDI | Class II | Active |
| Baha | 90429 | FDA UDI | Class II | Active |
| Baha | 90427 | FDA UDI | Class II | Active |
| Baha 5 Sound Processor, Brown | 95204 | FDA UDI | Class II | Active |
| Baha | 92129 | FDA UDI | Class II | Active |
| Cochlear | P770848 | FDA UDI | Class II | Active |
| Baha | 92846 | FDA UDI | Class II | Unknown |
| Cochlear Baha SoundBand unilateral, Mint | P1827032 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Blonde | P2054744 | FDA UDI | Class II | Active |
| Inner Case Baha 4/BP100 (Spare part) | 93196 | FDA UDI | Class II | Active |
| Baha | 90801 | FDA UDI | Class II | Active |
| Cochlear™ Baha® 6 Max Sound Processor, Blonde, 2mm | P1809177 | FDA UDI | Class II | Active |
| Baha SoundArc Extra Small | P1324401 | FDA UDI | Class II | Active |
| Cochlear Baha SounBand bilateral, Light Blue | P1827069 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook+ (Large, Maize) | P771907 | FDA UDI | Class II | Active |
| Cochlear™ Baha® 6 Max Sound Processor, Brown, 2mm | P1809180 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Copper | P2054748 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Black, 2mm | P2054772 | FDA UDI | Class II | Active |
| Abutment replica | 90374 | FDA UDI | Class II | Active |
| Abutment replica | 90374 | FDA UDI | Class II | Active |
| Healing cap with plug 30 mm | 95084 | FDA UDI | Class II | Active |
| Vistafix | 92998 | FDA UDI | Class II | Active |
| SP Magnet 5 | 95775 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook+ (Large, Carbon) | P771904 | FDA UDI | Class II | Active |
| Cochlear Baha SounBand bilateral, Brown | P1827072 | FDA UDI | Class II | Active |
| Cochlear Baha SoundBand unilateral, Red | P1827028 | FDA UDI | Class II | Active |
| Vistafix | 93100 | FDA UDI | Class II | Active |
| Cochlear™ Baha® 6 Max Sound Processor, Blonde | P1668389 | FDA UDI | Class II | Active |
| Vistafix | 92997 | FDA UDI | Class II | Active |
| Raspatorium | 90944 | FDA UDI | Class I | Active |
| Baha 7 Sound Processor, Blonde, 2mm | P2054771 | FDA UDI | Class II | Active |
| BIA310 Implant 4mm with 8mm abutment | P1340889 | FDA UDI | Class II | Active |
Related Companies
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Authorities
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Cochlear Bone Anchored Solutions Ab Molnlycke Vastra Gotaland · SE FEI 3003222064