Bernafon, Inc.
United StatesFDA applicant, unverified
Bernafon, Inc. is a medical device manufacturer, with 1,698 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 12 Nov 2026.
- Devices
- 1,698
Registry facts
- Registries
- FDA GUDID 1,682
- FDA 510(k) 16
- Device classes
- FDA Class II 1,484
- FDA Class I 214
What Bernafon, Inc. makes
The company manufactures air-conduction hearing aids in multiple form factors, including receiver-in-the-ear, behind-the-ear, in-the-ear, and canal styles. It also produces wireless-fitting computer-aided systems for hearing aids, remote controls for hearing aid/implant systems, and wireless induction loops for hearing aid use. Audiometric and hearing device software are part of its portfolio.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 1,698 devicesShowing 1-50 of 1,698
Frequently asked questions
How many devices does Bernafon, Inc. have in the registry?
The registry currently lists 1698 devices for Bernafon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bernafon, Inc.'s devices?
Among its 50 most recently registered devices, Bernafon, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Bernafon, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Bernafon, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bernafon, Inc. in the registry?
The most recently registered devices listed for Bernafon, Inc. include Bernafon 196496, Bernafon 205976, Bernafon 182064 and Bernafon 182148.