Hearing Solutions, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Hearing Solutions, Inc. makes
Hearing Solutions, Inc. manufactures a range of hearing aids, including full-shell, half-shell, and mini canal devices designed for behind-the-ear (BTE) and in-the-ear (ITE) use. Their portfolio includes custom-fit canal models (CIC), canal aids, and power hearing aids with adjustable sound selector features for tailored auditory support. Additional offerings include a series of 2N hearing aids in various form factors, as well as sound selector systems for ITE, BTE, and mini BTE applications.
The company’s devices are classified under Class I regulatory categories and are listed via FDA 510(k) clearance. These products are intended for use in the United States, where compliance with U.S. medical device regulations applies. No additional international registries or classifications are referenced in the available data.
Catalogue
Audio 'd' Sound Selector Power (Ssp) Ref K964180
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Audio 'd' Intima Cic Ref K961308
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 Hearing Solutions, Inc. have in the registry?
The registry currently lists 5 devices for Hearing Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hearing Solutions, Inc.'s devices?
Among its 5 most recently registered devices, Hearing Solutions, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Hearing Solutions, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Hearing Solutions, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hearing Solutions, Inc. in the registry?
The most recently registered devices listed for Hearing Solutions, Inc. include AUDIO 'D' SOUND SELECTOR POWER (SSP), AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS, AUDIO 'D' INTIMA CIC and SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM).