GN Hearing 21385800Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708296219469), received between Aug 7, 2024 and Jun 26, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ESTIMATED DATE OF INCIDENT ON (B)(6) 2025. IT HAS BEEN REPORTED THAT A RECEIVER SEPARATED AT THE POINT WHERE THE RED/BLUE PART MEETS THE GREY PART. IT HAPPENED OUTSIDE OF THE USER'S EAR, AND THERE WAS NO HARM FOLLOWING THE EVENT. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335135 ↗
• MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT A RECEIVER BROKE WHILE IN THE EAR CANAL AND GOT STUCK. THE USER WAS ABLE TO REMOVE IT HIMSELF, AND NO HARM RESULTED FROM THE INCIDENT. NO FURTHER FOLLOW UP IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898255 ↗
• MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT RECEIVERS SEPARATING AT THE END WHERE THE TIP/DOME ATTACHED/GLUED ON. SAME INCIDENT HAS HAVE HAPPENED BEFORE IN (B)(6) 2023. IT WAS REPORTED THAT PATIENT'S WIFE ASSISTED WITH THE REMOVAL THE FIRST TIME. NO THIRD PARTY ASSISTANCE REQUIRED FOR THE REMOVAL. EVENT DID NOT CAUSE HARM. HEARING CARE PROFESSIONAL REPLACED THE RECEIVER AND REPORTED INCIDENT TO THE MANUFACTURER. NO PATIENT CONSEQUENCES. NO HARM OR INJURY REPORTED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925984 ↗