General Hearing Instruments, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “General Hearing Instruments, Inc.” (first 1985, latest 2006), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 59 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 | 4 | 4 |
| KLW | Masker, Tinnitus | 1 | 1 |
Review panels
Most recent General Hearing Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061459 | TRANQUIL TRI-BTE | KLW | 2006-06-30 | 35 |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | ESD | 1998-03-06 | 77 |
| K971399 | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC | ESD | 1997-06-13 | 59 |
| K943144 | AURIS CIC | ESD | 1994-07-20 | 21 |
| K850123 | IN-TH-EAR HEARING AID | ESD | 1985-03-21 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named General Hearing Instruments, 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.
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.
- General Electric Co. (256 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Hearing Instruments, Inc.?
FDA lists 5 510(k) clearances under the applicant name “General Hearing Instruments, Inc.” (first 1985, latest 2006), across 2 product codes 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 General Hearing Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Hearing Instruments, Inc. is 59 days.
Which FDA product codes appear under General Hearing Instruments, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 4); KLW (Masker, Tinnitus, 1).
Next steps
- See all 5 General Hearing Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, General Hearing Instruments, 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 (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.