Authorized Hearing Systems, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Authorized Hearing Systems, Inc.” (first 1986, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 55 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 | 31 | 31 |
Review panels
- Ear, Nose and Throat (31)
Most recent Authorized Hearing Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971693 | RIONET HB-79P | ESD | 1997-06-06 | 30 |
| K970057 | AHS OMEGA SP | ESD | 1997-02-26 | 50 |
| K963878 | AHS OMEGA HF | ESD | 1996-12-06 | 71 |
| K963877 | AHS OMEGA CONCEPT | ESD | 1996-12-06 | 71 |
| K963875 | AHS OMEGA K-AMP | ESD | 1996-11-27 | 62 |
| K963881 | AHS DELTA 22 T | ESD | 1996-11-26 | 61 |
| K963879 | AHS DELTA 22 | ESD | 1996-11-26 | 61 |
| K963876 | AHS OMEGA PP | ESD | 1996-11-26 | 61 |
| K963874 | AHS OMEGA AGC | ESD | 1996-11-26 | 61 |
| K963873 | AHS OMEGA DEQ | ESD | 1996-11-26 | 61 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Authorized Hearing Systems, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Authorized Hearing Systems, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Authorized Hearing Systems, Inc.” (first 1986, latest 1997), 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 Authorized Hearing Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Authorized Hearing Systems, Inc. is 55 days.
Which FDA product codes appear under Authorized Hearing Systems, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 31).
Next steps
- See all 31 Authorized Hearing Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Authorized Hearing Systems, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.