Neuroears, Inc.
South KoreaFDA applicant, unverified
- Devices
- 1
What Neuroears, Inc. makes
NeuroEars, Inc. manufactures the NeuroEars-Anna™, a hearing aid designed for pediatric use, tailored to address specific auditory needs in children.
The company’s portfolio is regulated under Class II devices in the US, with the NeuroEars-Anna™ authorised via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
NeuroEars-Anna™ Ref K243709
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Neuroears, Inc. have in the registry?
The registry currently lists 1 device for Neuroears, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neuroears, Inc.'s devices?
Among its 1 most recently registered device, Neuroears, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Neuroears, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Neuroears, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neuroears, Inc. in the registry?
The most recently registered devices listed for Neuroears, Inc. include NeuroEars-Anna™.