RegWardenFDA facility compliance records
Facility

GN ReSound (Malaysia) Sdn. Bhd

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2019: 1 recalls20172018120192020202120222023202420252026
  • Recalls (1)

Devices registered here (1)

  • Hearing Aid, Air-Conduction With Wireless Technology, Prescription
    Product code OSM (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.3305

Recalls & enforcement

  • Class IITerminated2019-09-18
    GN 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…

Related

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 ReSound (Malaysia) Sdn. Bhd (FEI 3026048380) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3026048380-gn-resound-malaysia-sdn-bhd/

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