Audioscience, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Audioscience, Inc. makes
Audioscience, Inc. manufactures programmable hearing systems, including in-the-ear (ITE) and behind-the-ear (BTE) types, such as the PRIZM Hearing System and its Power BTE variant. These devices are designed to amplify sound for individuals with hearing loss, offering customizable settings for user-specific needs.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. The portfolio is regulated under US FDA standards, with devices authorised for commercial distribution in the United States.
Catalogue
Programmable Hearing System, Ite And Bte Types Ref K922422
510(k) 510(k)Prizm Hearing System Ref K930909
510(k) 510(k)Prizm Hearing System, Model Power Bte Ref K936007
510(k) 510(k)Prizm Hearing System Ref K902846
510(k) 510(k)
Frequently asked questions
How many devices does Audioscience, Inc. have in the registry?
The registry currently lists 4 devices for Audioscience, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Audioscience, Inc.'s devices?
Among its 4 most recently registered devices, Audioscience, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Audioscience, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Audioscience, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Audioscience, Inc. in the registry?
The most recently registered devices listed for Audioscience, Inc. include PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES, PRIZM HEARING SYSTEM and PRIZM HEARING SYSTEM, MODEL POWER BTE.