Sophono, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Sophono, Inc. makes
Sophono, Inc. manufactures bone conduction hearing systems, including the Otomag Bone Conduction Hearing System and its variants, such as the Model Alpha 1 (S) and (M) configurations. These devices are designed to transmit sound through the bones of the skull to the inner ear, bypassing the outer and middle ear.
The company’s bone conduction hearing systems fall under FDA Class II regulation and are recorded in the FDA’s 510(k) clearance registry. The devices are listed in the United States.
Catalogue
Otomag Bone Conducation Hearing System Ref K132189
Regimes: 510(k) Registry: 510(k)Otomag Bone Conduction Hearing System Ref K123962
Regimes: 510(k) Registry: 510(k)Otomag Bone Conduction Hearing System Ref K100193
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sophono, Inc. have in the registry?
The registry currently lists 5 devices for Sophono, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sophono, Inc.'s devices?
Among its 5 most recently registered devices, Sophono, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Sophono, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sophono, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sophono, Inc. in the registry?
The most recently registered devices listed for Sophono, Inc. include OTOMAG BONE CONDUCATION HEARING SYSTEM, OTOMAG BONE CONDUCTION HEARING SYSTEM, OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) and Sophono Bone Conduction Systems (S) Configuration and (M) Configuration.