GN ReSound 20686320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296145584), received between Sep 23, 2022 and Mar 21, 2024 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DATE OF INCIDENT: 10FEB2024. ON 22FEB2024 IT WAS REPORTED THAT THE USER HAD A LARGE TULIP DOME STUCK IN HIS EAR. HE PUT A NEW DOME ON 10FEB2024, AND WHEN TAKING THE HEARING AID OFF REALIZED THERE WAS NO DOME ON IT. AT THE TIME, HE DID NOT KNOW IT WAS STUCK INSIDE HIS EAR HE PUT ANOTHER DOME ON AND UPON WEARING THE HEARING AID, PUSHED THE DETACHED DOME FURTHER INTO HIS EAR. HE WENT TO A HEARING CARE PROVIDER WHO COULD NOT TAKE IT OUT, URGENT CARE COULD ALSO NOT RETRIEVE IT, BUT THE OTOLOGIST HE THEN WENT TO REMOVED IT IN 20 SECONDS. THERE WAS A SMALL SCAB IN HIS EAR, FROM URGENT CARE TRYING TO REMOVE THE DOME. USER REPORTS HAVING NO SYMPTOMS, AND THAT REMOVAL DID NOT HURT. THERE WAS NO HARM TO THE USER AS A RESULT OF THIS INCIDENT. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Abrasion

  MAUDE report 18948921 ↗
• MalfunctionSep 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  SF (B)(4). IT HAS BEEN REPORTED- BATTERIES ARE LEAKING FLUIDS INSIDE CASING. BASED ON THE AVAILABLE INFORMATION, THE EVENT IS CONSIDERED REPORTABLE AS THE MALFUNCTION MAY LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE PRODUCT HAS BEEN REPLACED. THIS IS AN INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473967 ↗