Hearing Aid Express: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hearing Aid Express” (first 1989, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time under this name: 36 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 | 5 | 5 |
Review panels
Most recent Hearing Aid Express 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942831 | HAE 2 | ESD | 1994-07-20 | 36 |
| K942830 | HAE 3 | ESD | 1994-07-20 | 36 |
| K942829 | HAE 1 | ESD | 1994-07-20 | 36 |
| K894428 | HEARING AID (IN-THE-EAR) | ESD | 1989-10-24 | 99 |
| K894414 | HEARING AID (IN-THE-CANAL) | ESD | 1989-09-27 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Hearing Aid Express.
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.
- Hearing Tech, Inc. (11 510(k)s)
- Hearing Solutions, Inc. (5 510(k)s)
- Hearing Aid Co. (4 510(k)s)
- Hearing Innovations, Inc. (3 510(k)s)
- Hearing Services, Inc. (3 510(k)s)
- Hearing Aid Crafters (2 510(k)s)
- Hearing Aids by Guy Horn (1 510(k)s)
- Hearing Care Products, Inc. (1 510(k)s)
- Hearing Components, Inc. (1 510(k)s)
- Hearing Crafters of America (1 510(k)s)
- Hearing Enhancement Center, Inc. (1 510(k)s)
- Hearing Health Care Program (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hearing Aid Express?
FDA lists 5 510(k) clearances under the applicant name “Hearing Aid Express” (first 1989, latest 1994), 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 Hearing Aid Express?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hearing Aid Express is 36 days.
Which FDA product codes appear under Hearing Aid Express?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 5).
Next steps
- See all 5 Hearing Aid Express clearances with predicates and recalls
- Run predicate analysis for product code ESD, Hearing Aid Express'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.