# GN Hearing A/S

- Location (FDA's records): Ballerup, DK
- FDA decisions: 5 (2018–2026): 5 510(k) clearances
- Product codes: KLW (3), QDD (1), QUH (1)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gn Resound A/S: 1 (https://510kreport.com/company/gn-resound-a-s)
- Bose Corporation: 1 (https://510kreport.com/company/bose)

## Its most-cited devices
- K181586: Tinnitus Sound Generator Module (2018), cited by 1
- K180495: Tinnitus Sound Generator Module (2018), cited by 1
- K213424: Jabra Enhance Plus (2022), cited by 1

## Recent decisions
- K254108: Jabra Enhance Select Self-fit (Jabra Enhance Select 550) (Jun 25, 2026)
- K213424: Jabra Enhance Plus (Jan 19, 2022)
- K193303: Tinnitus Sound Generator Module (Feb 20, 2020)
- K180495: Tinnitus Sound Generator Module (Nov 30, 2018)
- K181586: Tinnitus Sound Generator Module (Jul 13, 2018)

Source page: https://510kreport.com/company/gn-hearing-a-s