GN ReSound KE3CIC-W-MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296207497), received between Jul 7, 2023 and Jul 7, 2023 — 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.

• InjuryJul 7, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED (09-JUN-2023) THAT THE USER EXPERIENCED A BURNING SENSATION IN HER EAR CANAL, AFTER FALLING ASLEEP WITH HER COMPLETELY-IN THE-CANAL HEARING AID. THE ISSUE IS ONLY PRESENT ON ONE EAR. IT IS UNKNOWN WHICH EAR, IN THIS REPORT THE SERIAL NUMBER OF THE RIGHT HEARING AID IS INCLUDED. USER HAS HAD THE HEARING AIDS FOR APPROXIMATELY A YEAR. THE USER HAS NOT SEEN THE HCP, INSTEAD HER DAUGHTER CALLED IN TO REPORT THE INCIDENT. USER WENT TO URGENT CARE, AND HER DAUGHTER DESCRIBES THAT THE HEARING AID MELTED DOWN TO THE EARDRUM, HOWEVER, THERE IS VERY LIMITED INFORMATION ON THIS. THE USER STATES THAT HER EAR HURTS, AND THAT SHE CAN'T HEAR OUT OF IT. NO PICTURES OF HEARING AID, OR USERS EAR AVAILABLE. NO MEDICAL CONFIRMATION AVAILABLE.

  Patient problems: Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 17277576 ↗