GN ReSound 20928601Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05708296170975), received between Jan 13, 2020 and Jun 26, 2020 — classified as 3 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2020Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  AS REPORTED: PZ861DRWC FIRMWARE UPDATE ISSUE. WHEN PT ARRIVED I HOOKED UP HER AIDS AND BEGAN THE FIRMWARE UPDATE. AFTER FIRMWARE COMPLETION THE GAIN & PRESCRIPTIVE FORMULA FOR EACH EAR WAS SWAPPED. I CHECKED TO MAKE SURE EACH AID WAS ON THE CORRECT SIDE AND THEY WERE. TRIED RESETTING THE AIDS TO FACTORY SETTINGS AND UPLOADED A NEW AUDIOGRAM AS WELL BUT THE PROBLEM PERSISTED. INTERPRETATION: IF THE PATIENT USES THE DEVICES AND LEFT AND RIGHT HEARING AIDS HAS BEEN SWITCHED, USERS WITH ASYMMETRIC HEARING LOSS, CAN GET TOO LOUD SOUND IN THE EAR WITH THE LEAST HEARING LOSS. THIS POTENTIALLY CAN HARM THE REMAINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

  Patient problems: Hearing Impairment

  MAUDE report 10199561 ↗
• InjuryJun 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  DESCRIPTION FROM REPORTED EVENT: MEMBER CAME IN TO GET REXTON AIDS REPAIRED (B)(6) 2020 - MEMBER REPORTED A LOT OF PROBLEMS WITH RESOUND AIDS. THEN ON (B)(6) 2020 PICKED UP REPAIRED AID (DUE TO COVID) - WANTED TO RETURN RESOUND AIDS - HE SAID HE WENT TO ENT AND THEY PULLED OUT A DOME THAT WAS STUCK IN RIGHT EAR. ENT REPORTED EAR DRUM RUPTURE AND DRAINAGE (ACCORDING TO MEMBER). DRAINAGE STARTED END OF (B)(6) INTO (B)(6) 2020. WIFE HAD REMOVED SOME DOMES FROM OTHER EAR (NOT TOLD TO DISPENSER UNTIL 5/22/20). PREVIOUS REXTON AIDS HAVE SIZE 8-10 CLICK DOMES AND RESOUND DOMES WERE SAME SIZE (MEDIUM POWER DOMES). INTERPRETATION OF EVENT; IT SEEMS THE PATIENT HAD REXTON (MANUFACTURER IS A DIFFERENT MANUFACTURER, SIVANTOS) DEVICES REPAIRED AND RECEIVED RESOUND DEVICES (WE ARE THE MANUFACTURER) AS TEMPORARY REPLACEMENT DEVICES. IT IS THEN NOT QUITE CLEAR BUT IT SEEMS THE PATIENT HAD PROBLEMS WITH THE DOMES OF THE RESOUND DEVICES FALLING OFF IN THE EAR AND ONE OF THESE DOMES (PROBABLY OURS BUT COULD ALSO BE SIVANTOS) GOT STUCK IN THE EAR AND WERE REMOVED BY ENT, UNDER WHICH PROCEDURE THE EAR DRUM WAS RUPTURED. WE REPORT THIS EVENT AS IT CANNOT BE RULED OUT THAT OUR DOME WAS THE ONE THAT GOT S

  Patient problems: Perforation

  MAUDE report 10118464 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEMBER CAME INTO HEARING AID CENTER (HAC) WITH EAR INFECTION CLAIMING AIDS HAVE CAUSED IT. WANTS COMPLETE NEW SET. DISPENSER WILL NOT REFIT UNTIL MEDICAL CLEARANCE HAS BEEN GIVEN BY ENT. OCCURRED WITH RIGHT HEARING AID - EAR INFECTION PRESENT - WENT TO ENT FOR DIAGNOSIS. ENT SAID IT MIGHT HAVE BEEN CAUSED BY "CROSS CONTAMINATION OF DOMES" BUT HAC HAS STRICT SANITIZING PROCEDURE IN PLACE - THEY WERE DEMONSTRATED TO THE MEMBER. MEMBER IS NOW ON ANTI-BIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 9699812 ↗
• InjuryJan 13, 2020Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  SEVERE ALLERGIC REACTION FROM THE SEMI-OPEN DOMES, SCALING OF THE SKIN. END-USER HAS SEEN A DOCTOR TWICE. ANTIBIOTICS HAVE BEEN PRESCRIBED. BOTH EARS WERE AFFECTED.

  Patient problems: Irritation; Wheal(s)

  MAUDE report 9581421 ↗