GN ReSound 21230851Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296197736), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ESTIMATED DATE OF THE EVENT (B)(6) 2024 IT WAS REPORTED THAT THE USER WAS FITTED WITH A RECEIVER-IN-THE-EAR HEARING AID WITH THE ENCASED HIGH-POWER RECEIVER. A FEW DAYS LATER ((B)(6) 2023), THE SOUND IN THE RIGHT HEARING AID WAS INTERMITTENT. AFTER CHANGING THE BATTERY AND THE WAX GUARD, THE USER HEARD A LOUD SOUND IN HER RIGHT HEARING AID AND THEN A LOUD 'TOC' SOUND IN HER EAR. THE USER SAID IT WAS PAINFUL, THERE WAS SOME YELLOW LIQUID COMING OUT OF HER EAR AND BLOOD. THE USER WENT TO SEE GENERAL PRACTITIONER AND HE REPORTED THAT THE TYMPANIC MEMBRANE (TP) WAS COMPLETELY PERFORATED. THE USER WAS PRESCRIBED ANTIBIOTICS. HEARING CARE PROFESSIONAL (HCP) SAW THE USER IN (B)(6) 2024 AND REPORTED THAT THE USER'S TYMPANIC MEMBRANE LOOKED NORMAL. HCP REPORTED THAT IT LOOKED SLIGHTLY DIFFERENT FROM THE LEFT ONE, BUT STILL LOOKED NORMAL. THE USER DOES NOT HAVE HISTORY OF TP PERFORATIONS. HCP REFERRED THE USER TO AN OTOLARYNGOLOGIST TO GET CLEARANCE TO CONTINUE WEARING THE HEARING AIDS, OTOLARYNGOLOGIST GAVE THE CLEARANCE. HCP WILL REPLACE THE HEARING AIDS AND REMAKE EARMOLD WITH MEDIUM-POWER RECEIVER INSTEAD. NO FURTHER INFORMATION EXPECTED.

  Patient problems: Acoustic Trauma; Ear Pain; Perforation

  MAUDE report 18853720 ↗