Audina Hearing Instrument: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Audina Hearing Instrument” (first 1982, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 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 | 6 | 6 |
| LRB | Face Plate Hearing Aid | 2 | 2 |
Review panels
Most recent Audina Hearing Instrument 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964816 | AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR | ESD | 1997-01-17 | 49 |
| K953960 | HEARING AID (ALL-IN-THE-EAR) | ESD | 1995-09-12 | 21 |
| K942236 | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | LRB | 1994-06-17 | 39 |
| K936190 | BEHIND THE EAR HEARING AID | ESD | 1994-04-04 | 98 |
| K930271 | BEHIND-THE-EAR HEARING AID | ESD | 1993-03-18 | 58 |
| K897024 | MODEL AUDINA ITE HEATING AID | ESD | 1990-04-18 | 120 |
| K897023 | OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID | LRB | 1990-03-16 | 87 |
| K820833 | AUDICRAFT VIP HEARING AID | ESD | 1982-04-09 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Audina Hearing Instrument.
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 Audina Hearing Instrument?
FDA lists 8 510(k) clearances under the applicant name “Audina Hearing Instrument” (first 1982, latest 1997), 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 Audina Hearing Instrument?
The median time from FDA receipt to decision across 510(k)s cleared under the name Audina Hearing Instrument is 54 days.
Which FDA product codes appear under Audina Hearing Instrument?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 6); LRB (Face Plate Hearing Aid, 2).
Next steps
- See all 8 Audina Hearing Instrument clearances with predicates and recalls
- Run predicate analysis for product code ESD, Audina Hearing Instrument'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.