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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 8 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Abutment Cover SilverGray | 90746 | FDA UDI | Class II | Active |
| SP Magnet 6 | 95776 | FDA UDI | Class II | Active |
| Baha Fitting Software 7 | V 7.0 | FDA UDI | Class II | Active |
| Baha Softband bilateral, Pink | 95760 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Black | P2054745 | FDA UDI | Class II | Active |
| Guide pin 20 mm | 90796 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Actuator Unit | 95461 | FDA UDI | Class II | Active |
| Raspatorium/Probe | P1593725 | FDA UDI | Class I | Active |
| Impression coping squared for Vistafix VXA300 | 93192 | FDA UDI | Class II | Active |
| Vistafix | 92996 | FDA UDI | Class II | Active |
| Screwdriver UniGrip 95mm | 90469 | FDA UDI | Class I | Active |
| Vistafix | 93102 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook 2+ (XS) | P1173605 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Earhook+ (Medium, Maize) | P771903 | FDA UDI | Class II | Active |
| Cochlear™ Baha® 6 Max Sound Processor, Silver | P1668391 | FDA UDI | Class II | Active |
| BP100 & Baha 4 Battery door Soft black | 92084 | FDA UDI | Class II | Active |
| Baha 5 Sound Processor, Black | 95202 | FDA UDI | Class II | Active |
Related Companies
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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