Is this your brand? Sign in to claim ownership.
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 5 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baha | 91868 | FDA UDI | Class II | Unknown |
| BP100 & Baha 4 Tamper-proof battery door Champagne blonde | 92077 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Silver, 2mm | P2054773 | FDA UDI | Class II | Active |
| Baha | 93339 | FDA UDI | Class II | Active |
| Baha | 90432 | FDA UDI | Class II | Active |
| Cochlear™ Baha® 6 Max Sound Processor, Copper | P1668393 | FDA UDI | Class II | Active |
| Baha | 90410 | FDA UDI | Class II | Active |
| Baha | 90774 | FDA UDI | Class II | Active |
| Counter Torque Wrench | P1582231 | FDA UDI | Class I | Active |
| Cochlear™ Baha® Fitting Software 6 | P1701584 | FDA UDI | Class II | Active |
| Abutment cover blonde | 90744 | FDA UDI | Class II | Active |
| Baha | 90428 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Silver | P2054746 | FDA UDI | Class II | Active |
| Multi wrench with ISO adapter | 92143 | FDA UDI | Class I | Active |
| Baha | 92106 | FDA UDI | Class I | Active |
| Vistafix | 92995 | FDA UDI | Class II | Active |
| Cochlear™ Baha® 6 Max Battery Door, 10 pcs | P1668427 | FDA UDI | Class II | Active |
| Baha 4 sound processor, Ocean Blue | 93634 | FDA UDI | Class II | Unknown |
| Baha | 90620 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook+ (Medium, Smoke) | P771901 | FDA UDI | Class II | Active |
| Baha | 92837 | FDA UDI | Class II | Active |
| Bone Bed Indicator 14mm | P1578046 | FDA UDI | Class II | Active |
| BP100 & Baha 4 Battery door Iris Purple | 92574 | FDA UDI | Class II | Active |
| Baha | P1340896 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook+ (Medium, Mocha) | P771902 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Bodyworn cable | 95937 | FDA UDI | Class II | Active |
| Baha 5 Power, Brown | 95473 | FDA UDI | Class II | Active |
| Abutment Cover Black | 90745 | FDA UDI | Class II | Active |
| Screwdriver for hexagon 17mm | 90456 | FDA UDI | Class I | Active |
| Baha | 90625 | FDA UDI | Class II | Unknown |
| Baha | 93329 | FDA UDI | Class II | Active |
| Osscora Foot Control | 5046210 | FDA UDI | Class II | Active |
| Baha | 90802 | FDA UDI | Class II | Active |
| Vistafix | 92994 | FDA UDI | Class II | Active |
| Cochlear™ Baha® Fitting Software 6 | P1682914 | FDA UDI | Class II | Active |
| Baha | 92130 | FDA UDI | Class II | Active |
| Baha | 92140 | FDA UDI | Class II | Active |
| Bone bed indicator | 95180 | FDA UDI | Class I | Active |
| Baha | 93550 | FDA UDI | Class II | Active |
| Baha | 90417 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Processing unit | 96001 | FDA UDI | Class II | Active |
| Baha | 92844 | FDA UDI | Class II | Unknown |
| ISO adapter for Surgical wrench | 92353 | FDA UDI | Class II | Unknown |
| Baha 7 Sound Processor, Lavender, 2mm | P2114095 | FDA UDI | Class II | Active |
| SP Magnet 1 | 95771 | FDA UDI | Class II | Active |
| Baha 5 Battery Door, 10pcs | 95330 | FDA UDI | Class II | Active |
| Surgical organizer Ti | 90139 | FDA UDI | Class II | Unknown |
| Baha 5 SuperPower Actuator unit | 95464 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Lavender | P2114094 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook+ (Large, Smoke) | P771905 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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