GN ReSound 20419974Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296194483), received between Oct 14, 2022 and Oct 14, 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.

• InjuryOct 14, 2022Biocompatibility; Biocompatibility

  ON (B)(6) 2022: IT WAS REPORTED THAT THE NEXT DAY AFTER FITTING THE HEARING AIDS (HA) THE EAR CANALS STARTED ITCHING. USED COTTON SWAB TO RELIEVE ITCHING. WORE HA FOR 2 MORE DAYS THEN DISCONTINUED DUE TO PAIN. SINCE THE FITTING, THE PATIENT WORE HAS 2 DAYS IN A ROW THEN NEEDS TO LEAVE THEM OUT 3-4 DAYS TO RELIEVE RIGHT MORE THAN LEFT PAIN, SWELLING. LAST WORE HEARING AIDS ON (B)(6) 2022, SAW A PRIMARY CARE PROVIDER ON (B)(6) 2022. THE DOCTOR SAID HE HAD TO USE PEDIATRIC SPECULUM FOR OTOSCOPY AND PRESCRIBED ANTIBIOTIC OTIC DROPS 4 DROPS 2 X DAY FOR 7 DAYS. NO FOLLOW-UP APPT WITH THE DOCTOR REQUIRED. ON (B)(6) 2022 EAR CANALS WERE NOTED NOT RED, MAY BE SLIGHTLY SWOLLEN BUT USING ADULT SPECULUM FOR OTOSCOPIY. THE PATIENT WANTS TO KEEP TRYING WEARING HEARING AIDS. AUDIOLOGIST PLANS TO HAVE THE PATIENT RETURN FOR EMI FOR MICROMOLDS WILL HAVE SPECIAL INSTRUCTION FOR HYPOALLERGENIC TREATMENT. THE PATIENT DESCRIBED PAIN EXTENDING OUTSIDE EAR CANAL TO BEHIND EAR OUTSIDE TRAGUS AND PAIN WHEN OPENING JAW. COULD NOT SLEEP ON RIGHT SIDE OF HEAD. REACTION PRESENT ON BOTH EARS. PATIENT DOES NOT HAVE HISTORY OF ALLERGIES, HYPERSENSITIVITY, FUNGAL INFECTIONS, BUT CAN ONLY WEAR GOLD EARRINGS. NO ALL

  Patient problems: Ear Pain; Itching Sensation; Skin Discoloration; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 15605049 ↗