Ear-Tronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Ear-Tronics, Inc. makes
Ear-Tronics, Inc. manufactures in-the-ear (ITE) hearing aids, including custom-fit models and a range of pre-molded versions labeled M1 through M23. These devices are designed for behind-the-ear or canal placement to amplify sound for individuals with hearing loss.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. Ear-Tronics, Inc. is based in the United States.
Catalogue
Ite Hearing Aid, Ear-Tronics Models: M1-M23 Ref K881299
Regimes: 510(k) Registry: 510(k)Custom, In-The-Ear Hearing Aid Ref K821390
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ear-Tronics, Inc. have in the registry?
The registry currently lists 2 devices for Ear-Tronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ear-Tronics, Inc.'s devices?
Among its 2 most recently registered devices, Ear-Tronics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ear-Tronics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ear-Tronics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ear-Tronics, Inc. in the registry?
The most recently registered devices listed for Ear-Tronics, Inc. include ITE HEARING AID, EAR-TRONICS MODELS: M1-M23 and CUSTOM, IN-THE-EAR HEARING AID.