GN Hearing 23685475Recalls & reported problems
Gn Hearing A/S · HI,QG460S-C,RIE,N-BOX,SAND · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296386260), received between May 8, 2026 and May 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Detachment of Device or Device Component
IT HAS BEEN REPORTED THAT A USER HAD 2 DOMES GET STUCK IN HIS EAR, AND HAD TO HAVE THEM REMOVED BY A DOCTOR. THE USER EXPERIENCED NO HARM FOLLOWING THE INCIDENT. DESPITE ATTEMPTS, IT HAS NOT BEEN POSSIBLE TO GATHER FURTHER INFORMATION ON THE INCIDENT,. NO FURTHER FOLLOW UP HAS BEEN RECEIVED OR IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25121015 ↗MalfunctionMay 8, 2026Detachment of Device or Device Component
IT HAS BEEN REPORTED THAT A USER HAD A DOME STUCK IN HIS RIGHT EAR, AND HAD TO HAVE IT REMOVED AT URGENT CARE. THERE WAS NO INJURY TO THE EAR CANAL FOLLOWING THE INCIDENT, AND IT WAS REPORTED THAT THE DOME WAS REMOVED "VERY EASILY". NO FURTHER MEDICAL RECOMMENDATIONS WERE MADE. NO FURTHER FOLLOW UP HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25120891 ↗
Other Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter devices
- ACOSOUND Leya-W- BTE-MHangzhou AcoSound Technology Co.,Ltd. · Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter1 recall1 report
- GN Hearing 23685474Gn Hearing A/S · Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter2 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page