GN Hearing 22015870Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296221929), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE CUSTOMER WAS INSERTING RECIEVER INTO RIGHT EAR AND RED TIP OF THE RECEIVER BROKE OFF OR AWAY FROM THE GREY HOUSING OF THE RECEIVER AND GOT LOGGED IN THE EAR. THE CUSTOMER HAS EXTREMELY SMALL EAR CANALS. THE CUSTOMER DID HAVE TO SEEK MEDICAL HELP FOR REMOVAL OF THE RED RECEIVER TIP. AFTER REMOVAL, NO OTHER MEDICAL TREATMENT OF MEDICATION WAS PERFORMED/PRESCRIBED. NO HARM WAS DOCUMENTED BY MEDICAL DOCTOR. HCP IS GOING TO SEARCH FOR THE RIGHT SOLUTION FOR THE CUSTOMER WITH NEW HEARING AIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436754 ↗