GN Hearing 20863700Recalls & reported problems
Gn Hearing A/S · CHGR,PREM1,C-1,GEN,CFF3 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05708296147137), received between Mar 10, 2023 and Aug 4, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Overheating of Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Skin Burning Sensation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2023Overheating of Device; Overheating of Device
ON AN UNKNOWN DATE IN JULY (BEST ESTIMATE), PATIENT TRIED TO CHARGE HER HEARING AIDS OVER THE WEEKEND, BUT IT WASN'T CHARGING AT ALL. SHE CAME INTO CLINIC ON (B)(6) SO WE CAN HAVE A LOOK. THE TIP OF THE CORD WAS BENT, SO GAVE CLIENT A NEW CORD. CLIENT'S SON HAS COME IN ON 7TH OF JULY REPORTING THAT HE NOTICED THAT THE CHARGER WAS OVERHEATING ON THE BOTTOM AND THAT HE COULD SMELL A BURNING SMELL, SO HE INSTANTLY TOOK CHARGER OFF OF POWER. NO REPORT OF HARM TO PATIENT OR PROPERTY.ORIGINAL EQUIPMENT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17457442 ↗MalfunctionJul 26, 2023Overheating of Device; Overheating of Device
ESTIMATED DATE OF INCIDENT (B)(6) 2023. (B)(6) 2023 IT WAS REPORTED - CHARGER MELTED AT THE CHARGING PORT. IMAGES OBTAINED OF THE DEVICE SHOWED A MELTED CHARGER PORT. IT IS UNSURE IF SUPPLIED MICRO USB CABLE AND WALL SOCKET WERE USED. NO PATIENT HARM OR PROPERTY DAMAGE REPORTED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17397072 ↗MalfunctionJul 7, 2023Overheating of Device; Overheating of Device
ON (B)(6) 2023. ESTIMATED DATE OF INCIDENT (B)(6) 2023. ON 08JUN2023 IT WAS REPORTED: CHARGER BATTERY CAUGHT FIRE AT CONNECTING PORT. NO HARM TO PEOPLE OR PROPERTY. FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17278199 ↗MalfunctionJun 30, 2023Overheating of Device; Overheating of Device
IT IS REPORTED THAT THE CHARGER OVERHEATED AND IS TOTALLY MELTED WITH BLACK RESIDUE COMING OUT OFF IT, CHARGER IS CLEARLY MELTED AT THE POINT OF CONNECTION TO THE POWER CORD. PATIENT ALSO BURNED THEIR FINGER HOWEVER IT DID NOT REQUIRE MEDICAL ATTENTION. THIS IS AN INITIAL REPORT.
Patient problems: Skin Burning Sensation
MAUDE report 17238030 ↗MalfunctionMar 10, 2023Overheating of Device; Overheating of Device
ON (B)(6) 2023 PATIENT SAID SHE WENT TO GO GET HEARING AIDS OUT OF CHARGER AND COULD SMELL BURNING SO SHE LOOKED AT HER CHARGER AND NOTICED IT WAS MELTING. THERE WAS NO HARM TO THE PATIENT. ORIGINAL ACCESSORIES WERE USED. THE CHARGER WAS REPLACED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16520716 ↗
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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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