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GN Hearing 22448800Recalls & reported problems

Gn Hearing A/S · PKO,C-1,V3,JBR ENP,CFF2,US · Class 2

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 05708296255184), received between Jul 12, 2023 and Jul 12, 2023 — 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.

  • MalfunctionJul 12, 2023Overheating of Device; Overheating of Device

    ESTIMATED DATE OF INCIDENT: (B)(6) 2023. IT WAS REPORTED THAT THE CHARGER CABLE CONNECTOR IS MELTED INTO DEVICE. NO HARM TO THE USER OR PROPERTY HAS BEEN REPORTED. FURTHER FOLLOW UP IS EXPECTED. 10AUG2023. ON FOLLOW UP IT WAS CONFIRNED THAT THERE WAS NO HARM TO THE USER, AND THE DATE OF THE INCIDENT GIVEN. IT WAS ALSO REPORTED THAT THE ACCESSORIES USED WERE ORIGINAL. NO FURTHER FOLLOW UP IS EXPECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17304908 ↗

Other Hearing Aid, Air-Conduction with Wireless Technology, Prescription devices

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Sources and updates

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