Widex Hearing Aid Co., Inc.: FDA clearances and approvals
Widex Hearing Aid Co., Inc. has 52 FDA 510(k) clearances (first 1976, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time: 43 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 | 51 | 51 |
| KLW | Masker, Tinnitus | 1 | 1 |
Review panels
- Ear, Nose and Throat (52)
Most recent Widex Hearing Aid Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080955 | ZEN PROGRAM (MIND 440 HEARING AID) | KLW | 2008-06-27 | 85 |
| K971535 | WIDEX SENSO DIGITAL (MINI CANAL) | ESD | 1997-06-06 | 39 |
| K970904 | WIDEX SENSO DIGITAL (CIC) | ESD | 1997-03-26 | 14 |
| K965254 | WIDEX MODEL SENSO DIGITAL (C9) | ESD | 1997-03-12 | 72 |
| K965218 | SENSO DIGITAL (C18) | ESD | 1997-01-24 | 25 |
| K955879 | WIDEX MODEL SENSO DIGITAL (C16) | ESD | 1996-02-27 | 61 |
| K955878 | WIDEX MODEL SENSO DIGITAL (C8) | ESD | 1996-02-12 | 46 |
| K954526 | WIDEX SENSO DIGITAL (PX) | ESD | 1995-10-18 | 19 |
| K952229 | WIDEX MODEL LOGO 32 (L32) | ESD | 1995-06-19 | 38 |
| K946071 | LX-ITC | ESD | 1995-01-30 | 119 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Widex Hearing Aid Co., 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 Widex Hearing Aid Co., Inc. have?
Widex Hearing Aid Co., Inc. has 52 FDA 510(k) clearances (first 1976, latest 2008), across 2 product codes in 1 review panel.
How long does FDA take to clear Widex Hearing Aid Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Widex Hearing Aid Co., Inc.'s cleared 510(k)s is 43 days.
What devices does Widex Hearing Aid Co., Inc. make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 51); KLW (Masker, Tinnitus, 1).
Has Widex Hearing Aid Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Widex Hearing Aid Co., Inc. Related entities may recall under other names.
Next steps
- See all 52 Widex Hearing Aid Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Widex Hearing Aid Co., 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.