# Omni Hearing Systems

- Location (FDA's records): Mchenry, IL
- FDA decisions: 7 (1981–1984): 7 510(k) clearances
- Product codes: ESD (7)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K843921: IN the Canal Hearing Aid RC, Redicanal (Nov 1, 1984)
- K833333: IN the Ear Hearing Aid Omni 100 (Dec 8, 1983)
- K833451: Tel-Star Nuway & Generic E Asp-BP (Nov 14, 1983)
- K833334: Behind the Ear Asp-BB (Nov 14, 1983)
- K830459: Behind the Ear Hearing Aid Omni #OS (Mar 7, 1983)
- K823178: Tel-Star NU-Way & Generic E (Jan 7, 1983)
- K811158: OMNI (May 27, 1981)

Source page: https://510kreport.com/company/omni-hearing-systems