Decibel Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Decibel Instruments, Inc. makes
Decibel Instruments, Inc. manufactures articular hearing aids, which are designed for customizable acoustic fitting, and the Articulate Fitting System, a tool for adjusting and verifying hearing aid performance.
The company’s portfolio includes Class I and Class II devices, all of which are subject to FDA 510(k) clearance in the United States. The manufacturer is based in the US.
Catalogue
Articular Hearing Aids Ref K964603
Regimes: 510(k) Registry: 510(k)Articulate Fitting System Ref K973320
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Decibel Instruments, Inc. have in the registry?
The registry currently lists 2 devices for Decibel Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Decibel Instruments, Inc.'s devices?
Among its 2 most recently registered devices, Decibel Instruments, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Decibel Instruments, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Decibel Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Decibel Instruments, Inc. in the registry?
The most recently registered devices listed for Decibel Instruments, Inc. include ARTICULAR HEARING AIDS and ARTICULATE FITTING SYSTEM.