United Hearing Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What United Hearing Systems, Inc. makes
United Hearing Systems, Inc. manufactures programmable hearing aids, including behind-the-ear (BTE) models (MICRONET series) and custom in-the-ear (ITE/ITC) designs. Their portfolio also includes a bone conduction hearing aid for alternative sound transmission. All devices are designed for adults with varying degrees of hearing loss.
The company’s products are regulated under FDA Class I and Class II classifications, with most devices authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
Transear Bone Conduction Hearing Aid Ref K050653
510(k) 510(k)
Frequently asked questions
How many devices does United Hearing Systems, Inc. have in the registry?
The registry currently lists 3 devices for United Hearing Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list United Hearing Systems, Inc.'s devices?
Among its 3 most recently registered devices, United Hearing Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do United Hearing Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for United Hearing Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from United Hearing Systems, Inc. in the registry?
The most recently registered devices listed for United Hearing Systems, Inc. include UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901, 902, 903, 906, 909/PROGRAMMER, PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906, 911 and TRANSEAR BONE CONDUCTION HEARING AID.