GN ReSound 20574215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296089352), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryAug 26, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY THE LOCAL SALES OFFICE: MED OPEN DOMES CAUSE PATIENT'S EAR CANALS TO SWELL. MED OPEN DOMES. PATIENT HASN'T BEEN TO (B)(6) SINCE 2018. HE'S BEEN WEARING THE HAS INTERMITTENTLY. HE WEARS THEM FOR A WHILE, THEN HIS EAR CANALS SWELL - HE SETS THEM ASIDE UNTIL HIS EARS HEAL. HE TRIED WEARING THEM A MONTH AGO, BUT HIS EARS BECAME "WEEPY". HE SAW AN MD WHO PRESCRIBED ANTIBIOTICS 1ST, THEN ALLERGY MEDS. THE ALLERGY MEDS HELPED THE EAR CANALS TO HEAL. PATIENT REPORTS THAT HE HAS "A LOT" OF ALLERGIES, HIS EARS ARE VERY SENSITIVE. HE SWEATS A LOT, THE HAS HAVE FALLEN OUT B/C OF SWEAT. PATIENT USES BEATS "GLOBE" EARPHONES WHICH ARE HARD PLASTIC COVERED W/ "SILICONE OR RUBBER". THEY HAVE FALLEN OUT B/C OF SWEAT, BUT DO NOT CAUSE IRRITATION. PATIENT SPECULATES THAT IT'S B/C THE BEATS DON'T SIT VERY FAR IN HIS EARS. CUSTOMER REPORTS THAT PATIENT'S CANALS LOOK "DRY & RAW", SHE GAVE HIM "COMFORT EAR". SHE TOOK IMPRESSIONS TODAY FOR CUSTOM MOLDS, WILL F/U W/ TICKIE FOR RECOMMENDATION RE: CANAL LENGTH & MATERIAL. I WILL ENTER SAFETY QUESTIONS TOMORROW. COMPLAINT CREATED.

  Patient problems: Skin Irritation

  MAUDE report 10453433 ↗