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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 4 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SP Magnet 2 | 95772 | FDA UDI | Class II | Active |
| Cochlear Wireless Phone Clip | 94771 | FDA UDI | Class II | Active |
| Baha | 90408 | FDA UDI | Class II | Active |
| Baha 5 Inner Case | 95224 | FDA UDI | Class II | Active |
| Cochlear Wireless TV Streamer | 94761 | FDA UDI | Class II | Active |
| Abutment clamp | 90941 | FDA UDI | Class I | Unknown |
| Cochlear™ Baha® Fitting Software | P803255 | FDA UDI | Class II | Active |
| Baha 5 SuperPower Bodyworn cable | 95938 | FDA UDI | Class II | Active |
| BIA310 Implant 4mm with 10mm abutment | P1340890 | FDA UDI | Class II | Active |
| Baha 5 Power, Blonde | 95470 | FDA UDI | Class II | Active |
| Gold Cylinder 4mm | 90772 | FDA UDI | Class II | Active |
| Instrument Case | P1340904 | FDA UDI | Class II | Active |
| Baha Softband unilateral, Red | 95756 | FDA UDI | Class II | Active |
| Cochlear Baha SounBand bilateral, Pink | P1827064 | FDA UDI | Class II | Active |
| Baha sound processor Cleaning kit | 95458 | FDA UDI | Class II | Active |
| Cochlear Baha Remote Control 2 | 94791 | FDA UDI | Class II | Active |
| Baha | 92137 | FDA UDI | Class II | Active |
| Baha | 93363 | FDA UDI | Class II | Active |
| Baha | 93197 | FDA UDI | Class II | Active |
| Baha | 90362 | FDA UDI | Class II | Active |
| Baha | 95448 | FDA UDI | Class II | Unknown |
| Baha | 93357 | FDA UDI | Class II | Active |
| Baha | 93334 | FDA UDI | Class II | Active |
| Baha 7 Sound Processor, Mint, 2mm | P2054776 | FDA UDI | Class II | Active |
| Baha 5 Power, Silver | 95472 | FDA UDI | Class II | Active |
| Baha | 90434 | FDA UDI | Class II | Active |
| Cochlear Baha SoundBand unilateral, Brown | P1827037 | FDA UDI | Class II | Active |
| Baha | 90379 | FDA UDI | Class II | Active |
| Baha | 04032600 | FDA UDI | Class I | Active |
| Irrigation Tubing Set 3, 8 m | 91061 | FDA UDI | Class I | Active |
| BP100 & Baha 4 Battery door Apple Green | 92575 | FDA UDI | Class II | Active |
| Cochlear Baha SounBand bilateral, Red | P1827063 | FDA UDI | Class II | Active |
| Baha | 94175 | FDA UDI | Class II | Active |
| Baha | 90185 | FDA UDI | Class II | Unknown |
| BP100 & Baha 4 Battery door Glacier white | 92081 | FDA UDI | Class II | Active |
| Baha | 90450 | FDA UDI | Class II | Unknown |
| Baha | 93184 | FDA UDI | Class II | Active |
| Baha | 90480 | FDA UDI | Class II | Active |
| Baha | 95083 | FDA UDI | Class II | Active |
| BP100 & Baha 4 Battery door Ruby Red | 92572 | FDA UDI | Class II | Active |
| Baha | 92132 | FDA UDI | Class II | Active |
| Baha | 93338 | FDA UDI | Class II | Active |
| Baha | 93332 | FDA UDI | Class II | Active |
| Baha | 92133 | FDA UDI | Class II | Active |
| Baha Fitting Software 7 | V 7.0 | FDA UDI | Class II | Active |
| Baha | 93333 | FDA UDI | Class II | Active |
| Baha | 90067 | FDA UDI | Class II | Unknown |
| Indicator for Baha | 91095 | FDA UDI | Class I | Active |
| Baha | P1340898 | FDA UDI | Class II | Active |
| Baha | 91052 | FDA UDI | Class I | 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