Omni Hearing Systems: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Omni Hearing Systems” (first 1981, latest 1984), across 1 product code in 1 review panel. Median 510(k) review time under this name: 40 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 7 | 7 |
Review panels
Most recent Omni Hearing Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843921 | IN THE CANAL HEARING AID RC, REDICANAL | ESD | 1984-11-01 | 27 |
| K833333 | IN THE EAR HEARING AID OMNI 100 | ESD | 1983-12-08 | 72 |
| K833451 | TEL-STAR NUWAY & GENERIC E ASP-BP | ESD | 1983-11-14 | 40 |
| K833334 | BEHIND THE EAR ASP-BB | ESD | 1983-11-14 | 48 |
| K830459 | BEHIND THE EAR HEARING AID OMNI #OS | ESD | 1983-03-07 | 20 |
| K823178 | TEL-STAR NU-WAY & GENERIC E | ESD | 1983-01-07 | 73 |
| K811158 | OMNI | ESD | 1981-05-27 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Omni Hearing Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Omni Life Science, Inc. (21 510(k)s)
- Omni Intl., Inc. (12 510(k)s)
- Omni Therm, Inc. (5 510(k)s)
- Omni-Tract Surgical, Div. Minn. Scientific, Inc. (4 510(k)s)
- Omni-Guide Holdings, Inc. (2 510(k)s)
- Omni Sales Corp. (2 510(k)s)
- Omni Surgical, L.P. (2 510(k)s)
- Omni-Flow, Inc. (1 510(k)s)
- Omni-Glow, Inc. (1 510(k)s)
- Omni Medical Designs (1 510(k)s)
- Omni Mfg., Inc. (1 510(k)s)
- Omni Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omni Hearing Systems?
FDA lists 7 510(k) clearances under the applicant name “Omni Hearing Systems” (first 1981, latest 1984), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Omni Hearing Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omni Hearing Systems is 40 days.
Which FDA product codes appear under Omni Hearing Systems?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 7).
Next steps
- See all 7 Omni Hearing Systems clearances with predicates and recalls
- Run predicate analysis for product code ESD, Omni Hearing Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.