GN Hearing A/S
Medical device manufacturer in Ballerup, DK.
5510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550)QUH · Traditional | 06/25/2026SE |
| K213424 | Jabra Enhance PlusQDD · Traditional | 01/19/2022SE |
| K193303 | Tinnitus Sound Generator ModuleKLW · Special | 02/20/2020SE |
| K180495 | Tinnitus Sound Generator ModuleKLW · Traditional | 11/30/2018SE |
| K181586 | Tinnitus Sound Generator ModuleKLW · Special | 07/13/2018SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0584-2020 Class II | In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP…GN Hearing received reports from our manufacturing site in US regarding a software bug in our service &… | 09/18/2019Terminated |
| Z-0583-2020 Class II | Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW…GN Hearing received reports from our manufacturing site in US regarding a software bug in our service &… | 09/18/2019Terminated |