GN Hearing 19709500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296140800), received between May 18, 2022 and May 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• InjuryMay 18, 2022Material Fragmentation; Material Fragmentation

  (B)(4)-ENCASED MICRO-MOLD,3 PIN,MP(B)(4) DURING NORMAL WEARING, THE SHELL IS SUDDENLY BROKEN AND THE EXTERNAL EAR SCRATCH. THE DEVICE BROKE WHEN USING AT HOME. THE OBJECT WAS REMOVED BY THE USER AND CAUSED BLEEDING. THE USER HAS NOT EXPERIENCED THIS BEFORE. THE USER HAS BEEN IN CONTACT WITH A MEDICAL PRACTIONER AND NO TREATMENT WAS GIVEN. THE MEDICAL PRACTIONER COMMENTED- THE EAR LOOKS NOT SO SERIOUS AND REMEMBER NOT TO TOUCH WATER.

  Patient problems: Localized Skin Lesion

  MAUDE report 14431559 ↗