Micro-Ear Hearing Center, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Micro-Ear Hearing Center, Inc. makes
Micro-Ear Hearing Center, Inc. manufactures custom in-the-ear hearing aids, including low-profile, full-concha, and canal designs tailored for behind-the-ear fitting. These devices are intended for individuals requiring discreet, form-fitted hearing solutions.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the United States.
Catalogue
Micro-Ear Low-Profile In-The-Ear Hearing Aid Ref K870081
Regimes: 510(k) Registry: 510(k)Micro-Ear Full-Concha In-The-Ear Hearing Aid Ref K870080
Regimes: 510(k) Registry: 510(k)Micro-Ear Canal In-The-Ear Hearing Aid Ref K870079
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Micro-Ear Hearing Center, Inc. have in the registry?
The registry currently lists 3 devices for Micro-Ear Hearing Center, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micro-Ear Hearing Center, Inc.'s devices?
Among its 3 most recently registered devices, Micro-Ear Hearing Center, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Micro-Ear Hearing Center, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Micro-Ear Hearing Center, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Micro-Ear Hearing Center, Inc. in the registry?
The most recently registered devices listed for Micro-Ear Hearing Center, Inc. include MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID, MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID and MICRO-EAR CANAL IN-THE-EAR HEARING AID.