GN Hearing 23685474Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296386253), received between Jun 3, 2026 and Sep 10, 2026 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Patient Device Interaction Problem

  Date of incident (b)(6) 2026.It was reported that the user developed a severe ear infection in both ear canals after wearing the hearing aids for a few days. The user added that she has eczema in both ears and has had ear infections before. The user is being treated by her Ear-Nose-Throat (ENT) doctor but the specific treatment is unknown. No harm to the user has been reported.No further follow up is available.

  Patient problems: Ear infection; Hypersensitivity/Allergic reaction

  MAUDE report 50709950 ↗
• MalfunctionJun 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A USER MIGHT HAVE GOTTEN A SMALL SIZED DOME STUCK INSIDE THEIR EAR. UPON REMOVAL OF THE HEARING AID FROM THE EAR, THE DOME WAS FOUND TO NO LONGER BE ATTACHED AND IT IS PRESUMED TO BE IN THE EAR CANAL, HOWEVER, THIS HAS NOT BEEN CONFIRMED. THE USER WAS ADVISED TO SEEK MEDICAL HELP TO GET THE DOME REMOVED. THERE WAS AN APPOINTMENT WITH HEARING CARE PROFESSIONAL SCHEDULED. THE OUTCOME IS NOT REPORTED. NO HARM WAS REPORTED. FUTHER INFORMATION ON THIS INCIDENT IS NOT AVAILABLE OR EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25370459 ↗