GN ReSound 21508700Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296193516), received between Sep 23, 2022 and Sep 23, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Biocompatibility; Biocompatibility

  HCP REPORTED A PATIENT DEVELOPING 'CONTACT DERMATITIS' FROM WEARING HEARING AIDS. HEARING AIDS WERE FITTED IN (B)(6) 2022, BUT THE SYMPTOMS DID NOT DEVELOP BEFORE RECENTLY. HCP WERE MAKING A "REQUEST" TO REMAKE DEVICE TO BE MORE HYPOALLERGENIC. SPECIFICALLY ACRYLIC MOLDS TO BE REMADE WITH SILICONE MATERIAL. HCP REPORTED REDNESS/IRRITATION AND INFLAMMATION ON BACKSIDE OF PINNA AND AT THE OPENING OF EAR CANAL, BOTH EARS. THE PATIENT IS UNDER CARE OF ENT. ENT CONFIRMED THE PATIENT DEVELOPING 'CONTACT DERMATITIS'. THE PATIENT WAS PRESCRIBED A STEROID CREAM, WHICH PATIENT REPORTS IS HELPING THE SYMPTOMS. HCP RECOMMENDS CONTINUING CARE WITH ENT AS WELL AS TO REMAKE EARMOLDS WITH HYPOALLERGENIC MATERIAL. HCP IS ALSO GOING TO TRY SWEAT BANDS TO SLIP OVER THE CASING OF THE HEARING AIDS TO PREVENT DIRECT CONTACT BETWEEN HEARING AID CASING AND THE EAR. IT WAS NOT POSSIBLE TO RECEIVE A FOLLOW UP WHETHER HEARING AIDS WERE REMADE TO MORE HYPOALLERGENIC, OR IF THERE WAS POSSIBLE CONTACT WITH OTHER ALLERGENS AND IF THE PATIENT HAS A HISTORY OF ALLERGIES HYPERSENSITIVITY OR FUNGAL INFECTIONS. IT WAS ALSO NOT POSSIBLE TO CONFIRM, IF THE PATIENT IS FULLY RECOVERED. NO FURTHER FOLLOW UP INFORMATION EX

  Patient problems: Contact Dermatitis; Inflammation; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 15474620 ↗