Truetone Hearing Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Truetone Hearing Systems, Inc. makes
Truetone Hearing Systems, Inc. manufactures hearing aid components, including faceplate kits for hearing aids and in-the-ear hearing aid devices designed for custom fitting.
The company’s products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Faceplate (Hearing Aid Kit) Ref K954236
510(k) 510(k)In-The-Ear Hearing Aid Ref K945710
510(k) 510(k)
Frequently asked questions
How many devices does Truetone Hearing Systems, Inc. have in the registry?
The registry currently lists 2 devices for Truetone Hearing Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Truetone Hearing Systems, Inc.'s devices?
Among its 2 most recently registered devices, Truetone Hearing Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Truetone Hearing Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Truetone Hearing Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Truetone Hearing Systems, Inc. in the registry?
The most recently registered devices listed for Truetone Hearing Systems, Inc. include FACEPLATE (HEARING AID KIT) and IN-THE-EAR HEARING AID.