Omni Hearing Systems
Country not established
- Devices
- 7
What Omni Hearing Systems makes
Omni Hearing Systems manufactures a range of hearing aids, including behind-the-ear models such as the OMNI #OS and ASP-BB, in-the-ear devices like the OMNI 100, and in-the-canal options including the RC and REDICANAL. Their portfolio also includes telecoil-equipped hearing aids, such as the TEL-STAR NU-WAY and its generic variants, designed for improved sound transmission in various environments.
The company’s devices are classified under Class I in the US and are listed via FDA 510(k) submissions. These products are regulated under US medical device laws and are intended for commercial distribution within the United States.
Catalogue
Tel-Star Nu-Way & Generic E Ref K823178
Regimes: 510(k) Registry: 510(k)Behind The Ear Hearing Aid Omni #os Ref K830459
Regimes: 510(k) Registry: 510(k)Behind The Ear Asp-Bb Ref K833334
Regimes: 510(k) Registry: 510(k)In The Ear Hearing Aid Omni 100 Ref K833333
Regimes: 510(k) Registry: 510(k)In The Canal Hearing Aid Rc, Redicanal Ref K843921
Regimes: 510(k) Registry: 510(k)Tel-Star Nuway & Generic E Asp-Bp Ref K833451
Regimes: 510(k) Registry: 510(k)Omni Ref K811158
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omni Hearing Systems have in the registry?
The registry currently lists 7 devices for Omni Hearing Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omni Hearing Systems's devices?
Among its 7 most recently registered devices, Omni Hearing Systems has devices listed in FDA 510(k) (7 devices).
What risk classes do Omni Hearing Systems's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Omni Hearing Systems's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Omni Hearing Systems in the registry?
The most recently registered devices listed for Omni Hearing Systems include TEL-STAR NU-WAY & GENERIC E, BEHIND THE EAR HEARING AID OMNI #OS, BEHIND THE EAR ASP-BB and IN THE EAR HEARING AID OMNI 100.