GN ReSound 21303875Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296194575), received between Oct 6, 2022 and Dec 21, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryDec 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  21DEC2022. ON 21NOV2022 IT WAS REPORTED: 'PATIENT WAS FIT ON (B)(6) 2022 AND RETURNED TO THE CLINIC ON (B)(6) 2022 WITH COMPLAINT OF IRRITATION IN HER EARS. HEARING CARE PROVIDER (HCP) CHANGED DOMES FROM LARGE OPEN TO MEDIUM OPEN TO SEE IF THAT WOULD HELP. PATIENT HAD NOT COME IN OR CONTACTED HCP UNTIL SHE CAME INTO THE OFFICE TODAY AND HAS BEEN ON ANTIBIOTICS FOR A WEEK. THE SYMPORTMS REPORTED AS 'BLISTER, INFECTION', RIGHT SIDE OUTER EAR INFCETION; LEFT SIDE 'BUBBLING IN THE EAR CANAL'. REACTION PRESENT ON BOTH EARS, LOCATED IN THE EAR CANAL. PATIENT DID NOT REPORT HAVING THIS REACTION BEFORE. REACTION IS NOT RELATED TO PHYSICAL FIT OF THE HEARING AIDS. PATIENT REPORTED HAVING A LATEX ALLERGY. PATIENT WAS IN CONTACT WITH MEDICAL PROVIDER, AND GOT ANTIBIOTICS PRESCRIBED. IT IS NOT KNOWN, IF MEDICAL PROVIDER PERFORMED TESTS FOR BACTERIA AND/OR FUNGI. HCP IS GOING TO LOOK INTO THE INGREDIENTS IN THE "AUDIOWIPES" SHE RECOMMENDED PATIENT USE. PATIENT USES AUDIOWIPES AND DID NOT THINK TO LOOK INTO THE INGREDIENTS OF THOSE OR STOP USING THEM TO SEE IF THEY ARE CAUSING AN ISSUE. HCP MAY CALL BACK TO ORDER ACRYLIC EARMOLDS/HOLLOW CAVITY EARMOLDS FOR THE PATIENT. FOLLOW UP RECIEVED ON 14DE

  Patient problems: Blister; Ear infection

  MAUDE report 16022501 ↗
• InjuryOct 6, 2022Biocompatibility; Biocompatibility

  AFTER BEING FIT WITH THE RESOUND ONE 7 RIE DEVICES, CLINICIAN REPORTED THAT END USER RECEIVED A SEVERE REACTION TO THE NEW LIGHT GREY DOMES, RESULTING IN INFLAMMATION AND BLEEDING WITHIN BOTH EAR CANALS. PORTION IN FRONT OF THE EAR (ANTERIOR TO TRAGUS AND HELIX) WAS ALSO REPORTED TO HAVE SOME IRRITATION FROM THE RECEIVERS. THE REACTION BEGAN A COUPLE OF DAYS AFTER INITIAL FITTING, AND THE END USER COULD NOT USE THE DEVICE UNTIL FOLLOW UP APPOINTMENT, WHICH WAS TWO WEEKS AFTER. NO KNOWN HISTORY OF ALLERGIES OR HYPERSENSITIVITY. THE USER WAS IN CONTACT WITH AUTHORIZED MEDICAL PRACTITIONER, WHO REPORTED IT TO BE AN ALLERGIC REACTION OF SOME KIND TO THE DEVICES. TOPICAL CREAM WAS PRESCRIBED FOR TREATMENT. RECOMMENDATION FROM HEALTH CARE PROFESSIONAL WAS TO FIT CUSTOM MOULDS WITH HYPOALLERGENIC COATING. CLINICIAN REPORTED THAT THE USER'S EAR HAS SINCE HEALED AND ARE NOW WEARING CANAL LOCK MOULDS WITH NO REPORTED ALLERGIC REACTIONS.

  Patient problems: Dry Skin; Ear infection; Hypersensitivity/Allergic reaction; Inflammation; Local Reaction

  MAUDE report 15549673 ↗