GN Hearing A/S
FDA Regulatory Profile
GN Hearing A/S appears in FDA public data with 2 recalls, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0583-2020, Class II) was initiated on September 18, 2019. Its most recent 510(k) clearance was granted on June 25, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0583-2020 | Class II | Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964 | September 18, 2019 |
| Z-0584-2020 | Class II | In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-H | September 18, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | June 25, 2026 |
| K213424 | Jabra Enhance Plus | January 19, 2022 |
| K193303 | Tinnitus Sound Generator Module | February 20, 2020 |
| K180495 | Tinnitus Sound Generator Module | November 30, 2018 |
| K181586 | Tinnitus Sound Generator Module | July 13, 2018 |