Opticon Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Opticon Corp. makes
Opticon Corp. manufactures behind-the-ear (BTE) hearing aids, including multifocus models, and ear-level (EARETTE) hearing aids designed for customised sound amplification.
These devices are classified as Class I under US regulations and are listed via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Earette Hearing Aid Ref K780699
Regimes: 510(k) Registry: 510(k)Bte Hearing Aid Multifocus Ref K915614
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Opticon Corp. have in the registry?
The registry currently lists 2 devices for Opticon Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opticon Corp.'s devices?
Among its 2 most recently registered devices, Opticon Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Opticon Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Opticon Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Opticon Corp. in the registry?
The most recently registered devices listed for Opticon Corp. include EARETTE HEARING AID and BTE HEARING AID MULTIFOCUS.