GN ReSound 20574204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296088546), received between May 11, 2023 and Jun 1, 2023 — classified as 2 injuries.

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 18, 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.

• InjuryJun 1, 2023Misassembly by Users; Misassembly by Users

  ON (B)(6) 2023, PATIENT STATED DOME BECAME LODGED IN HIS EAR AND WAS STIL LODGED IN HIS EAR WHEN CUSTOMER SERVICE AGENT CALLED TO ASK FOLLOW-UP QUESTIONS ((B)(6) 2023). PATIENT DID NOT DESCRIBE ANY OTHER SYMPTOMS OR HARM. PATIENT STATED THAT WERE WAITING TO SEE IF DOME WILL WORK ITS WAY OUT. PATIENT HAD FITTED IN NEW DOMES BY THEMSELVES 3+ WEEKS EARLIER. ON AN UNKNOWN DATE, PATIENT WENT TO ER TO REMOVE DOME FROM HIS EAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037084 ↗
• InjuryMay 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6) 2023 (B)(6) 2023 AN EMAIL WAS RECEIVED FROM USER: ABOUT TWO WEEKS AGO, THE EAR MOLD ON MY DISCONNECTED AND BECAME STUCK IN MY EAR. THE ISSUES WAS UNKNOWN FOR ABOUT A WEEK. A SIGNIFICANT EAR INFECTION OCCURRED. TO REMOVE THE PLASTIC EAR MOLD, A DOCTOR'S VISIT WAS REQUIRED. THE AUTHORIZED MEDICAL PRACTITIONERS REMOVED THE DOME FROM THE EAR. NO IRRITATION OR PUNCTURE OF TYMPANIC MEMBRANE. USER TOLERATED PROCEDURE WELL. DURING THE MEDICAL PRACTITIONER VISIT THE USER STATED HE EXPERIENCED MILD EAR PAIN AND SOME RASH 1-4 WEEKS PRIOR TO EVENT. THE USER TRIED EAR DROPS FOR THE SYMPTOMS. THE USER HAS A KNOWN HISTORY OF CHRONIC EAR INFECTION. HEARING AIDS WERE PROFESSIONALLY REVIEWED AND CLEANED BY COSTCO AUDIOLOGY ABOUT 2 MONTHS AGO. DEVICE HISTORY: PURCHASED 1.26.2018/ SN: (B)(4). HEARING AID IS USED WITH SPORTS LOCK DEVICE HAS NEVER BEEN IN FOR ANY SERVICE TO OUR FACILITY. CONTACT STORE FOR SERVICE HISTORY: (B)(6) 2020, COMPLAINT LEFT AID WEAK, CLEAN & CHECK, (B)(6) 2021, CLEAN & CHECK, (B)(6) 2022 CLEAN AND CHECK, (B)(6) 2022 CLEAN AND CHECK, REPLACED DOME, FILTER AND SPORT LOCK. RECEIVER HAS NEVER BEEN REPLACED. WILL FOLLOW UP WITH HEARING CARE PROVIDER TO SEE IF CUSTOM EARMOLD I

  Patient problems: Ear infection

  MAUDE report 16909964 ↗