GN ReSound 20928608Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296171019), received between Nov 13, 2020 and Dec 4, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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.

• InjuryDec 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  EVENT DESCRIPTION AS REPORTED BY USER/PATIENT: PT WORE AIDS SINCE (B)(6) 2020 AND EVERYTHING WAS FINE. ABOUT 6-8 WEEKS AGO DEVELOPED THEY STARTED ITCHING AND "WEEPING" WENT TO THE MD AND WAS TOLD THAT IT'S LIKELY AN ALLERGY TO THE LATEX IN THE DOMES. WAS GIVEN EARDROPS DUE TO AN INFECTION FROM SCRATCHING THE EARS. HAS A F/U DOCTORS APPOINTMENT IN ABOUT A MONTH AND WAS ADVISED NOT TO WEAR THESE AIDS UNTIL THAT TIME. POTENTIAL SAFETY CASE. GOT AIDS IN (B)(6) 2020 AND THIS STARTED ABOUT 6-8 WEEKS AGO. WORE PRIOR RESOUND AIDS WITH THE CLEAR DOMES FOR 6+ YEARS WITH NO ISSUES. COMMENT BY LOCAL CUSTOMER SERVICE & MANUFACTURER: NEITHER THE "CLEAR" DOMES NOR ANY OTHER TYPE OF DOMES CONTAINS LATEX.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Skin Irritation

  MAUDE report 10947943 ↗
• InjuryNov 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY LOCAL CUSTOMER SERVICE: HCP CALLING TO GET INFORMATION ABOUT METALS IN RECEIVER AS PATIENT REPORTING ITCHINESS. PATIENT CALLED HCP TO FIND OUT WHETHER THERE IS NICKEL IN OUR RECEIVERS. PATIENT IS REPORTING ITCHINESS IN BOTH EARS. THE PATIENT SAID SHE WENT TO THE DOCTOR AND THEY GAVE HER CORTISONE FOR HER EARS. THE HCP SAID THAT THE PATIENT HAS STOPPED WEARING THE INSTRUMENTS. SHE USES TULIP DOMES. THE HCP SAID THAT THE PATIENT DOES NOT HAVE A SIMILAR REACTION WHEN SHE USES HER OLD INSTRUMENTS WHICH ARE FORZAS. SHE WAS FIT IN JULY, AND WHEN SHE WAS FIT INITIALLY, SHE INITIALLY COMPLAINED OF MILD ITCHINESS. HOWEVER, SHE HAS NOT COME IN WITH THAT COMPLAINT SINCE HER INITIAL FITTING. THEY SET AN APPOINTMENT FOR THE PATIENT TO COME INTO THE OFFICE ON OCTOBER 22ND. THE HCP SAID THAT THE PATIENT IS VERY SENSITIVE TO METALS IN JEWELRY, AND TYPICALLY GETS A RASH WITH METAL JEWELRY. THE HCP WAS UNABLE TO ANSWER ANY SPECIFIC QUESTIONS AS THE PATIENT WAS NOT THERE AND SHE HAS NOT BEEN ABLE TO EXAMINE HER EARS. I WILL BE EMAILING HER FOLLOW-UP QUESTIONS. COMPLAINT CREATED.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Skin Irritation

  MAUDE report 10835001 ↗