GN Hearing 21385500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05708296219438), received between Jun 4, 2024 and Nov 8, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ESTIMATED DATE OF INCIDENT ON (B)(6) 2024. ON 09OCT2024, IT WAS REPORTED THAT THE USER'S RECEIVER HAD BROKEN IN THE USER'S EAR. HE HAD BEEN WEARING IT AS NORMAL, WHEN IT DETACHED. THE HEARING CARE PROFESSIONAL WAS ABLE TO REMOVE THE RECEIVER. NO HARM TO THE USER WAS REPORTED. NO FURTHER FOLLOW UP IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638751 ↗
• MalfunctionOct 18, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ESTIMATED DATE OF INCIDENT: (B)(6) 2024 IT HAS BEEN REPORTED THAT THE HEARING CARE PROVIDER AND SEVERAL COLLEAGUES HAVE EXPERIENCED THAT THE PLASTIC PART OF HEARING AID RECEIVERS COME APART. CLINIC WAS UNABLE TO SPECIFY HOW MANY TIMES THIS HAS HAPPENED. THERE HAS BEEN NO REPORTS THAT ANY OF THE RECEIVERS GOT STUCK IN ANY USER'S EAR, AND NO REPORT THAT ANY HARM FOLLOWED THE INCIDENTS. FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479150 ↗
• MalfunctionOct 11, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT THE LEFT RECEIVER BROKE ON (B)(6) 2024. THE RECEIVER BROKE IN THE USER'S EAR THERE IS NO INDICATION IN THE USER'S FILE THAT THE RECEIVER REQUIRED REMOVAL. NO HARM OR INJURY FOLLOWING THE INCIDENT. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425606 ↗
• MalfunctionOct 8, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT THE LEFT RECEIVER BROKE ON (B)(6) 2024. THE RECEIVER BROKE WHILE THE HEARING AID WAS BEING CLEANED. USER WAS UNAWARE OF THE BREAK AND THE RECEIVER WAS CHANGED. NO OBJECT WAS STUCK IN THE EAR, NO HARM OR INJURY FOLLOWING THE INCIDENT. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396860 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT CAME IN THE OFFICE OF THE HEARING CARE PROFESSIONAL FOR HIS 4 MONTH SERVICE APPOINTMENT ON AUGUST 29TH. WHILE CLEANING THE HEARING AID AND REMOVING THE LEFT DOME, THE TOP PART OF THE RECEIVER FELL OFF. IT NEVER CAME OFF IN THE PATIENT'S EAR. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319117 ↗
• MalfunctionJun 4, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  ESTIMATED DATE OF INCIDENT (B)(6) 2024. IT WAS REPORTED THAT THE TOP HOUSING SEPARATED FROM THE BOTTOM HOUSING ON THE RECEIVER OF THE HEARING AID WHILE THE HEARING CARE PROFESSIONAL WANTED TO SWAP OUT DOMES. NO HARM TO THE USER WAS REPORTED. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457876 ↗