GN ReSound KE2ITC-DW-MPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296207428), received between Sep 21, 2022 and Sep 21, 2022 — 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.

• InjurySep 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 25-AUG-2022 IT WAS REPORTED THAT THE PATIENT ON UNKNOWN DATE CHANGED FROM CUSTOM HEARING AID TO RECEIVER-IN-CANAL HEARING AID, BECAUSE OF INFECTION IN BOTH EAR CANALS. THE PATIENT EXPERIENCED PAIN IN THE EAR CANAL, WHEN THE HEARING AIDS WERE IN DURING THE DAY, AND BECAUSE OF THE PAIN THEY WERE REMOVED. AT NIGHT THE PATIENT EXPERIENCED DRAINAGE. SYMPTOMS REPORTED: REDNESS, PAIN, INFLAMMATION AND EAR DISCHARGE/FLUID. THE PATIENT HAS NEVER EXPERIENCED THIS BEFORE. HEARING AID ARE A YEAR OLD AND THE PAIN WAS RECENT. NO KNOWN HISTORY OF ALLERGIES OR HYPERSENSITIVITY. ON UNKNOWN DATE, THE PATIENT WAS IN CONTACT WITH A MEDICAL PRACTIONER, WHO CONCLUDED THAT THE DRAINAGE WAS NON-INFECTIOUS, NO WOUNDS IN THE EAR CANAL OR CONCHA BOWL AND NO EFFUSION, AND RECOMMENDED THAT THE PATIENT SWITCHED TO A BEHIND-THE-EAR HEARING AID STYLE OR REFIT THE CUSTOM DEVICES AND FOLLOW-UP IN 3 MONTHS. PAIN IS SUSPECTED TO BE RELATED TO THE PHYSICAL FIT OF THE HEARING AIDS.

  Patient problems: Ear Pain; Erythema; Fluid Discharge; Skin Inflammation/ Irritation

  MAUDE report 15461173 ↗