GN Hearing A/S: FDA clearances and approvals
GN Hearing A/S has 5 FDA 510(k) clearances (first 2018, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 90 days. Since 2017 its median was 90 days, against 178 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named GN Hearing A/S. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 152 |
| 2019 | 0 | — |
| 2020 | 1 | 83 |
| 2021 | 0 | — |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 188 |
Review time against the same product codes
Since 2017, GN Hearing A/S's cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KLW | Masker, Tinnitus | 3 | 3 |
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | 1 | 1 |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | 1 | 1 |
Review panels
Most recent GN Hearing A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | QUH | 2026-06-25 | 188 |
| K213424 | Jabra Enhance Plus | QDD | 2022-01-19 | 90 |
| K193303 | Tinnitus Sound Generator Module | KLW | 2020-02-20 | 83 |
| K180495 | Tinnitus Sound Generator Module | KLW | 2018-11-30 | 277 |
| K181586 | Tinnitus Sound Generator Module | KLW | 2018-07-13 | 28 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-09-18.
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.
Device clinical trials
GN Hearing A/S is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04823494: Wear-Time Trial for Self-Fitting Hearing Aid (Completed, started 2021-06-18)
Frequently asked questions
How many FDA 510(k) clearances does GN Hearing A/S have?
GN Hearing A/S has 5 FDA 510(k) clearances (first 2018, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear GN Hearing A/S's 510(k)s?
The median time from FDA receipt to decision across GN Hearing A/S's cleared 510(k)s is 90 days. Since 2017: 90 days, versus 178 days for all cleared 510(k)s in the same product codes.
What devices does GN Hearing A/S make?
Its most frequent FDA product codes are KLW (Masker, Tinnitus, 3); QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription, 1); QUH (Self-Fitting Air-Conduction Hearing Aid, Over The Counter, 1).
Has GN Hearing A/S had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches GN Hearing A/S; the most recent began 2019-09-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 GN Hearing A/S clearances with predicates and recalls
- Run predicate analysis for product code KLW, GN Hearing A/S'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.