GN ReSound 19861108Recalls & reported problems
Gn Hearing A/S · HI,EN998-DW,BLK · Class 2
All models of GN ReSound (106)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819286987), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (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.
Most reported problems
Device problems
- Overheating of Device1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2022Overheating of Device; Patient Device Interaction Problem; Overheating of Device; Patient Device Interaction Problem
ON (B)(6) 2022 IT WAS REPORTED THE CASE OF THE HEARING AID HAD MELTED. THERE WAS NO HARM TO THE USER AND THE USER DID NOT SEE AN AUTHORIZED MEDICAL PRACTITIONER. NO MEDICAL/SURGICAL INTERVENTION NECESSARY. IT WAS REPORTED THAT VISUAL INSPECTS REVEALED SOME MOISTURE AND WAX AROUND THE CASE, AND THAT LISTENING CHECK REVEALED GOOD VOLUME AND SOUND QUALITY. IT WAS REPORTED THAT THE MELTED SPOT COULD BE FROM A HEATING SOURCES OUTSIDE, SUCH AS CURLY ION, HAIR BLOW DRYER OR MICROWAVE. THE DEVICE IS NOT A RECHARGEABLE DEVICE AND FUNCTIONING WITH BATTERIES. IT WAS REPORTED TO SHOW NO SIGNS OF DAMAGING INSIDE BATTERY COMPARTMENT OR INTERNAL COMPONENTS AND HEARING AID IS STILL FUNCTIONING AS EXPECTED. USER STATES THE HEARING AID WAS ALWAYS IN HIS CASE OR ON HIS EAR, AND NEVER TOUCHED ANYTHING HOT TO CAUSE MELTING. REPAIR WAS DONE AND PATIENT WAS FINE AFTER REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15368472 ↗
Other Hearing aid, air conduction with wireless technology devices
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- GN Hearing 21655200Gn Hearing A/S · Hearing aid, air conduction with wireless technology8 reports
- Beltone 20623200Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- Beltone 21625700Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- GN Hearing 20863700Gn Hearing A/S · Hearing aid, air conduction with wireless technology5 reports
- Phonak Audéo I90-Sphere (graphite gray)Sonova AG · Hearing Aid, Air-Conduction With Wireless Technology, Prescription5 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 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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