Bernafon, Inc.: FDA clearances and approvals
Bernafon, Inc. has 16 FDA 510(k) clearances (first 1983, latest 1988), across 1 product code in 1 review panel. Median 510(k) review time: 42 days.
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 | 16 | 16 |
Review panels
- Ear, Nose and Throat (16)
Most recent Bernafon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880349 | MODEL 759 CUSTOM IN-THE-EAR HEARING AID | ESD | 1988-03-07 | 41 |
| K874589 | BERNAFON COLIBRI, C-2H HEARING AIDS | ESD | 1987-12-04 | 25 |
| K864823 | BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1 | ESD | 1987-01-06 | 28 |
| K864180 | INTEGRA, CUSTOM IN-THE-EAR HEARING AID | ESD | 1986-11-05 | 9 |
| K860759 | CHARISMA HEARING AID | ESD | 1986-04-11 | 42 |
| K855240 | BEHIND THE EAR HEARING AIDS MODEL | ESD | 1986-03-12 | 71 |
| K851547 | BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 | ESD | 1985-05-29 | 43 |
| K844985 | IN THE EAR MODEL X-ITE 84 | ESD | 1985-01-23 | 28 |
| K844621 | BEHIND THE EAR HEARING AID BERNAFON T-88P | ESD | 1985-01-07 | 41 |
| K844425 | BEHIND THE EAR HEARING AIDS BERNAFON X-13 | ESD | 1985-01-04 | 50 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bernafon, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bernafon, Inc. have?
Bernafon, Inc. has 16 FDA 510(k) clearances (first 1983, latest 1988), across 1 product code in 1 review panel.
How long does FDA take to clear Bernafon, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bernafon, Inc.'s cleared 510(k)s is 42 days.
What devices does Bernafon, Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 16).
Has Bernafon, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bernafon, Inc. Related entities may recall under other names.
Next steps
- See all 16 Bernafon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Bernafon, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.