GN Hearing 21654700Recalls & reported problems
Gn Hearing A/S · EM,RIE-HA-RF8-HPSF3 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296210367), received between May 7, 2026 and Jun 17, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Ear infection1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A RIGHT SIDE HEARING AID MIGHT HAVE CAUSED AN EAR INFECTION. IT WAS ALLEGED THAT THE HEARING AID TOUCHED THE TYMPANIC MEMBRANE. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: Ear infection
MAUDE report 25532153 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE WAXGUARD GROMMET FELL OUT OF BOTH MICRO EARMOLDS WHILE THE HEARING CARE PROFESSIONAL (HCP) WAS ATTEMPTING TO CHANGE THE GN WAX FILTER. THE GROMMET DID NOT FALL INTO THE USER'S EAR BUT FELL OFF WHEN REPLACING THE WAXGUARDS. THEREFORE, NO MEDICAL ATTENTION WAS REQUIRED, AND THE USER DID NOT SEEK MEDICAL HELP. NO FURTHER SYMPTOMS WERE REPORTED. NO HARM TO THE USER HAS BEEN REPORTED. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111044 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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