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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 2 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Baha | 90397 | FDA UDI | Class II | Active |
| BIA310 Implant 4mm with 6mm abutment | P1340888 | FDA UDI | Class II | Active |
| Baha | 90784 | FDA UDI | Class II | Active |
| Baha | 90416 | FDA UDI | Class II | Active |
| BP100 & Baha 4 Tamperproof battery door Sky Blue | 92571 | FDA UDI | Class II | Active |
| Baha | 90778 | FDA UDI | Class II | Active |
| Fixture ST 4mm | 90440 | FDA UDI | Class II | Active |
| Baha | 90780 | FDA UDI | Class II | Active |
| SP Magnet 3 | 95773 | FDA UDI | Class II | Active |
| Baha | 92840 | FDA UDI | Class II | Unknown |
| Counter Torque Wrench | HIA 009-0 | FDA UDI | Class I | Active |
| Cochlear Baha SoundBand unilateral, Lavender | P2126554 | FDA UDI | Class II | Active |
| Baha | 95460 | FDA UDI | Class II | Active |
| Baha | 91051 | FDA UDI | Class I | Active |
| SP Magnet 4 | 95774 | FDA UDI | Class II | Active |
| Driver Pin | 90356 | FDA UDI | Class II | Active |
| Baha Softband bilateral, Black | 95764 | FDA UDI | Class II | Active |
| Impression coping squared | 90379 | FDA UDI | Class II | Active |
| Baha | 90068 | FDA UDI | Class II | Unknown |
| Guide pin 20 mm | 90796 | FDA UDI | Class II | Active |
| Baha Programming Cable Long Red | 91914 | FDA UDI | Class II | Active |
| Screwdriver Unigrip 20mm | 90459 | FDA UDI | Class I | Active |
| Baha | 95948 | FDA UDI | Class II | Active |
| Baha 5 Demo, Black | 95207 | FDA UDI | Class II | Active |
| Baha | 90380 | FDA UDI | Class II | Active |
| Baha | 90426 | FDA UDI | Class II | Active |
| Baha | P1340897 | FDA UDI | Class II | Active |
| Baha Magnetic battery removal tool | 92252 | FDA UDI | Class II | Active |
| Baha Safety line | 90711 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Demo, Black, 2mm | P2054777 | FDA UDI | Class II | Active |
| Cochlear Baha SoundBand unilateral, Black | P1827060 | FDA UDI | Class II | Active |
| Screwdriver for Tamperproof | 92657 | FDA UDI | Class II | Active |
| Baha Softband unilateral, Red | 95757 | FDA UDI | Class II | Active |
| Baha | 90430 | FDA UDI | Class II | Active |
| Baha | 92144 | FDA UDI | Class II | Active |
| Baha | 92346 | FDA UDI | Class II | Active |
| Baha Programming Cable Short Red | 91912 | FDA UDI | Class II | Active |
| Baha 5 Sound Processor, Copper | 95205 | FDA UDI | Class II | Active |
| Baha | 92126 | FDA UDI | Class II | Active |
| Cochlear Baha SounBand bilateral, Black | P1827075 | FDA UDI | Class II | Active |
| BP100 & Baha 4 Battery door Slate grey | 92083 | FDA UDI | Class II | Active |
| Baha Softband bilateral, Light blue | 95761 | FDA UDI | Class II | Active |
| Baha 4 sound processor, Champagne blonde | 93630 | FDA UDI | Class II | Unknown |
| Baha Indicator | P1582203 | FDA UDI | Class I | Active |
| Baha | 90629 | FDA UDI | Class II | Unknown |
| Baha | 92836 | FDA UDI | Class II | Active |
| Baha | 90627 | FDA UDI | Class II | Unknown |
| Baha | 91891 | FDA UDI | Class I | Active |
| Cochlear Baha SoundBand unilateral, Pink | P1827029 | FDA UDI | Class II | Active |
| Baha | 90360 | 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