GN ReSound 21339774Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296191307), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING THE PROGRAMMING PROCESS THERE WAS A LOUD SOUND IN THE LEFT EAR WHICH SOUNDED SOMEWHAT LIKE THE FEEDBACK TEST AND IT DISCONNECTED THE AID. IT RECONNECTED BUT CUSTOMER IS NOT CONFIDENT THE AID IS FIXED. THE FEEDBACK DID NOT SEEM LOUD ENOUGH TO CAUSE ACOUSTIC TRAUMA BUT I WANT TO BE VERY CAREFUL WITH THIS. QUESTIONNAIRE: WAS THE SOUND PAINFUL AND/OR DID IT CAUSE HARM TO THE PATIENT OR OTHER PERSON? POTENTIALLY. HAS THE PATIENT BEEN IN CONTACT WITH A PROFESSIONAL? NO. PLEASE CHOOSE THE DURATION OF THE SOUND? UP TO 10 SECONDS. WHAT TYPE OF RECEIVER? HIGH POWER.

  Patient problems: Partial Hearing Loss; Skin Irritation

  MAUDE report 10904647 ↗