Hearing Services, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Hearing Services, Inc. makes
Hearing Services, Inc. manufactures custom and pre-molded hearing aids designed to fit within the ear or canal, including face plates for in-the-ear devices and fully custom canal and in-the-ear models. Their products are tailored for individual wearers, with options like the HSI Model C and HSI Elite #EC, which are molded to fit specific ear anatomies. These devices are intended for amplifying sound for users with hearing loss.
The company’s hearing aids fall under Class I regulatory classification in the US, with devices listed via FDA 510(k) clearance. Their portfolio is regulated under the US Food and Drug Administration’s medical device authorities, and the company operates from the United States.
Catalogue
In The Ear & In The Canal Hearing Aid Face Plate Ref K871884
Regimes: 510(k) Registry: 510(k)Hsi Model C. Custom In-The-Ear Hear/Aid Ref K790737
Regimes: 510(k) Registry: 510(k)Hsi Elite #ec Custom Canal Hear-Aid Ref K832701
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hearing Services, Inc. have in the registry?
The registry currently lists 3 devices for Hearing Services, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hearing Services, Inc.'s devices?
Among its 3 most recently registered devices, Hearing Services, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Hearing Services, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hearing Services, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hearing Services, Inc. in the registry?
The most recently registered devices listed for Hearing Services, Inc. include IN THE EAR & IN THE CANAL HEARING AID FACE PLATE, HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID and HSI ELITE #EC CUSTOM CANAL HEAR-AID.