GN Hearing A/S
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Face Plate Hearing AidProduct code LRB (opens in a new tab) · Class I · Ear, Nose, Throat · 21 CFR 874.3300
Recalls & enforcement
- Class IITerminated2019-09-18GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain…
FDA inspections (1)
- VAI2018-08-23Voluntary Action Indicated · Compliance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
- All facilities operated by GN Hearing A/S
- GN ReSound (Malaysia) Sdn Bhd. (MY)
- GN Hearing Care Corporation (MN)
- GN ReSound (Malaysia) Sdn. Bhd (MY)
- GN RESOUND CHINA, LTD. (CN)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “GN Hearing A/S (FEI 3005650109) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005650109-gn-hearing-a-s/
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