Data / Medical devices / Hearing Aid, Bone Conduction, Implanted
Hearing Aid, Bone Conduction, Implanted (MAH): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Hearing Aid, Bone Conduction, Implanted (product code MAH, Class 2, 21 CFR 874.3302). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on August 26, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MAH
- Device class
- 2
- Regulation
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Sweden | 5 |
| Poland | 1 |
| Switzerland | 1 |
| France | 1 |
Makers of Hearing Aid, Bone Conduction, Implanted
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Oticon Medical AB | Askim Vastra Gotaland, Sweden | Complaint file establishment, Specification developer | 6 | August 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cochlear Bone Anchored Solutions AB | Molnlycke Vastra Gotaland, Sweden | Manufacturer | 3 | December 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cenova AB | MJOLBY Ostergotland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demant Operations Poland Sp. z o.o. | Mierzyn Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply IH AB | MOLNDAL Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elos Medtech Timmersdala AB | TIMMERSDALA Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maillefer Instruments Holding Sarl | BALLAIGUES Vaud, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Group | SAINT-PRIEST Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.