GN Hearing 21654600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708296210350), received between Jun 29, 2022 and May 8, 2026 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A WAXGUARD HAD FALLEN OUT OF A RIGHT SIDE HEARING AID EARMOULD. THE WAX GUARD FELL OUT OUTSIDE OF THE EAR, WHILE ATTEMPTING TO CHANGE THE WAX GUARD. THERE WAS NO HARM TO THE USER FOLLOWING THE INCIDENT. NO FURTHER FOLLOW UP IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25121101 ↗
• MalfunctionJun 28, 2024Fracture; Fracture

  ON (B)(6) 2024 THE USER COULD NOT INSERT THE EARMOULD IN HER EAR. USER CAME INTO CLINIC AND THE CLINIC FOUND THAT THE EARMOULD WAS BROKEN NEAR THE VENT AREA AND RETRIEVAL LINE WAS BROKEN AS WELL. IT HAS BEEN REPORTED THERE WAS NO HARM TO USER, NO REQUIREMENT TO REMOVE EARMOULD AND NO MEDICAL INTERVENTION NEEDED. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631506 ↗
• InjuryJun 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  (B)(6) 2022/RE: INITIAL REPORTABILITY RATIONALE. THE CURRENT INFORMATION INDICATES NEED FOR REPORTING. ATTACHED REPORTING DECISION TREE SUPPORT THE REPORTABILITY DECISION. BASED ON THE EVENT DESCRIPTION AND THE RISK REGISTER REFERENCE THE EVENT/ INCIDENT DID LEAD TO, OR MIGHT LED TO A SERIOUS INJURY. THE EVENT DESCRIBED 'PLEASE MAKE EARMOLD SMALLER, INCREASE VENTING, AS THE OLD ONE CAUSE INFECTION'. IT WAS REPORTED THAT THE EARMOLDS WERE TIGHT ALL OVER ON BOTH EARS. AFTER FEW WEEKS OF WEARING THEM, IT STARTED TO HURT THE PATIENT'S EARS, GIVING FOLLOWING SYMPTOMS IN THE EAR CANALS: REDNESS, PAIN, PRESSURE, SORES AND INFECTIVE. THE USER HAS NO KNOW HISTORY OF HYPERSENSITIVITY OR FUNGAL INFECTIONS. THE PATIENT HAS BEEN IN CONTACT WITH A MEDICAL PROFESSIONAL WHO RECOMMENDED EAR DROPS AND TO LET BOTH EARS HEAL BEFORE WEARING ANYTHING IN EARS. ON 22-JUN-2022, ADDITIONAL INFORMATION WAS PROVIDED: STATE PATIENT STARTED WEARING THE EARMOLDS IS MICHIGAN. DATE OF WHEN PATIENT'S EAR GOT SORE, 2ND WEEK OF JUNE FROM THE INITIAL FITTING. DOCTOR PRESCRIBE ANTIBIOTIC EARDROPS, MOST COMMONLY KNOWN AS EAR CLEAR. PLEASE PROVIDE MEDICAL HISTORY (COMORBIDITIES) THIS INFORMATION IS N/A. PLEASE PROVIDE PH

  Patient problems: Discomfort; Localized Skin Lesion; Skin Discoloration; Skin Infection

  MAUDE report 14850690 ↗