Precision Hearing Instruments
Country not established
- Devices
- 1
What Precision Hearing Instruments makes
Precision Hearing Instruments manufactures custom hearing aids, including full-shell in-the-ear (ITE) devices, low-profile designs, helix models, and canal combinations with a soft dome (SD) or canal tip. These products are tailored for behind-the-ear (BTE) and in-the-ear (ITE) fittings, with specific configurations for discreet or secure placement in the ear canal.
The company’s portfolio is classified under Class I medical devices in the US, with devices authorised via the FDA’s 510(k) pathway. Products are listed in the FDA’s 510(k) database, adhering to regulatory requirements for hearing aids. The manufacturer operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Precision Hearing Instruments have in the registry?
The registry currently lists 1 device for Precision Hearing Instruments. Devices recorded under merged duplicate company entries are counted once.
Which registries list Precision Hearing Instruments's devices?
Among its 1 most recently registered device, Precision Hearing Instruments has devices listed in FDA 510(k) (1 device).
What risk classes do Precision Hearing Instruments's devices fall under?
Among its 1 most recently registered device, the classes recorded for Precision Hearing Instruments's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Precision Hearing Instruments in the registry?
The most recently registered devices listed for Precision Hearing Instruments include FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA.