GN ReSound 19420808Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819268341), received between Oct 2, 2020 and Oct 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryOct 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED BY THE LOCAL SALES OFFICE: MEDIUM OPEN DOMES CAUSING REDNESS, SWELLING AND A RASH IN BOTH EAR CANALS. THE PATIENT HAS WORN THESE AIDS FOR 4 YEARS AND HAS RECENTLY DEVELOPED AN ALLERGY TO THE DOMES. THEY CALLED IN TO SEE WHAT MATERIAL THE DOMES WERE MADE OF. LET THEM KNOW IT WAS MEDICAL GRADE SILICONE. RECOMMENDED CUSTOM MICRO MOLDS FOR THE RICS. AUDIOLOGIST WILLING TO GIVE IT A TRY. SHE HAS WORN AIDS FOR 4 YEARS NOW, AND DEVELOPED THE ALLERGY 3.5 YEARS AFTER BEING FIT. NOTICED 6 MONTHS AGO. GETS BETTER WHEN AIDS ARE OUT OF EARS. SAW DERMATOLOGIST WHO CLEARED IT UP BUT IT IS BACK AGAIN. DERMATOLOGIST DID AND PATCH TEST WITH DOME CONTACTING THE ARM- AND IT CAUSED REDNESS ON THE ARM. RECOMMENDS TRYING A DIFF OPTION- MATERIAL. USER HAS A HISTORY OF ALLERGIES. OCCASIONALLY REACTS TO ADHESIVE FROM BAND-AIDS. INTERPRETATION BY CORPORATE QUALITY, PMS&V TEAM: OUR DOMES LIKELY CAUSED ALLERGIC REACTION. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Irritation

  MAUDE report 10618723 ↗