GN Hearing 22420175Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296254897), received between Jun 2, 2023 and Jul 12, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT HAS BEEN REPORTED THAT- HCP CALLED TO STATE THAT SHE FIT HER PATIENT (B)(6) 2023 AND THAT THE PATIENT HAS HAD 2 EAR INFECTIONS SINCE THEN (4/25 AND CURRENTLY IN JUNE). THE PATIENT IS NOT IN THE STORE WITH THE HEARING CARE PROFESSIONAL (HCP). PATIENT CALLED THE HCP ABOUT 30 MINS AGO TO STATE THAT SHE HAD 2 EAR INFECTIONS SINCE FEB AND WAS TOLD BY HER PRIMARY CARE PHYSICIAN (PCP) THAT THE DOMES WERE RESPONSIBLE FOR THE INFECTIONS. THE DOCTOR HAS PRESCRIBED DROPS FOR BOTH EARS PER HCP THE FIRST TIME IT HAPPENED. SHE IS NOT SURE OF WHAT TREATMENT THE PATIENT IS UNDERGOING AT THIS TIME. PATIENT'S HUSBAND PASSED RECENTLY AND WILL NOT BE COMING IN TO SEE THE HCP FOR AT LEAST A WEEK. HCP WANTS TO KNOW WHAT OTHER OPTIONS OUTSIDE THE DOMES THE PATIENT HAS BECAUSE THE PATIENT IS INTERESTED IN KEEPING THE DEVICES AND WEARING THEM, BUT WITHOUT THE EAR INFECTIONS. FOLLOW UP REPORTED: NO PHOTOS AVAILABLE. THE HCP IS NOT AWARE IF AREA ON/IN THE EAR HAVE BEEN EXPOSED TO OTHER CHEMICALS. HCP THINKS IT DEVELOPED SLOWLY OVER 2-3 WEEKS NO KNOWN HISTORY OF ALLERGIES. HCP RECOMMENDED SHE NOT WEAR THE DEVICES UNTILL SHE SPOKE WITH HER DOCTOR.

  Patient problems: Unspecified Infection

  MAUDE report 17304882 ↗
• InjuryJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED: RECEIVER DOME AND RED PART OF RECEIVER FELL OFF IN MEMBER'S EAR. MEMBER WAS ABLE TO GET IT OUT IN THE OFFICE. NO FURTHER SYMPTOMS WERE REPORTED. NO FURTHER FOLLOW UP RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048998 ↗