GN ReSound 21539700Recalls & reported problems
Gn Hearing A/S · CHGR PREMV2,C-1,RS,VA,CFF1 · 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 05708296200214), received between Nov 18, 2022 and Nov 18, 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 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.
MalfunctionNov 18, 2022Overheating of Device; Overheating of Device
ON 16-NOV-2022, IT WAS REPORTED THAT HEARING AID BATTERY CHARGER OVERHEATED AND MELTED AT POWER PORT. PATIENT DID NOT RETURN THE POWER CORD, THEREFORE CLINICIAN UNABLE TO DETERMINE IF THAT CORD WAS THE ONE ISSUED WITH THE CHARGER UNIT. NO HARM TO THE PATIENT OR PROPERTY DAMAGE IS REPORTED. ON 01-OCT-2022 FROM B3 IS A BEST ESTIMATE, THE EXACT DATE OF THE INCIDENT IS NOT KNOWN. FOLLOW UP REQUEST HAS BEEN SENT, NO FOLLOW UP RECIEVED YET. ON 14-DEC-2022, FOLLOW UP INFORMATION RECIEVED ON 06DEC2022: HCP REPORTED: PATIENT REPORTED NOT BEING HARMED, BUT DID REPORT SOME BLACK MELTED REMAINS FROM THE CORD ON HIS FINGERTIPS. HE WAS ASKED IF SEEN BY PCP OR ER AND HE DENIED STATING THAT THE INCIDENT DID NOT REQUIRE THIS. NO FURTHER FOLLOW UP INFORMATION EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15823752 ↗
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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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