Hear Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Hear Co., Inc. makes
Hear Co., Inc. manufactures hearing aid accessories, including the ATTENU-CHEK device for measuring hearing aid output levels and the HEARCO C, a hearing aid coupler used for acoustic testing and calibration.
The company’s portfolio includes Class I and Class II devices, all of which are authorised via the FDA’s 510(k) pathway. These products are listed under the US regulatory framework and are based in the United States.
Catalogue
Attenu-Chek Ref K802350
Regimes: 510(k) Registry: 510(k)Hearco C Ref K831129
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hear Co., Inc. have in the registry?
The registry currently lists 2 devices for Hear Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hear Co., Inc.'s devices?
Among its 2 most recently registered devices, Hear Co., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hear Co., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hear Co., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hear Co., Inc. in the registry?
The most recently registered devices listed for Hear Co., Inc. include ATTENU-CHEK and HEARCO C.