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GN Hearing 22420174Recalls & reported problems

Gn Hearing A/S · HI,EP161-C,RIE,BRNZ · 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 05708296254880), received between May 11, 2023 and May 11, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (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

  • Product Quality 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.

  • MalfunctionMay 11, 2023Product Quality Problem; Product Quality Problem

    IT HAS BEEN REPORTED THAT RECEIVER BROKE A TIP(BLUE TIP WITH DOME ATTACHED REMAINED IN HIS EAR CANAL). THIS HAPPENED FOR THE FIRST TIME. THE PATIENT DID SEEK MEDICAL HELP TO REMOVE THE OBJECT FROM THE EAR. NO FURTHER SYMPTOMS WERE REPORTED. NO HARM CAUSED AND NO TREATMENT NEEDED. THE PATIENT HAS RECEIVED NEW REPLACEMENT DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16909291 ↗

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

All Hearing Aid, Air-Conduction with Wireless Technology, Prescription devices →

Sources and updates

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