Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

GN Hearing A/S

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories3
Latest FDA decision2026-06-25
TypeNumberDevice NameCodeDateActions
510(k) K254108 Jabra Enhance Select Self-fit (Jabra Enhance Select 550)QUH2026-06-25 View
510(k) K213424 Jabra Enhance PlusQDD2022-01-19 View
510(k) K193303 Tinnitus Sound Generator ModuleKLW2020-02-20 View
510(k) K180495 Tinnitus Sound Generator ModuleKLW2018-11-30 View
510(k) K181586 Tinnitus Sound Generator ModuleKLW2018-07-13 View