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GN ReSound 21495902Recalls & reported problems

Gn Hearing A/S · HI,KE361-DRW,MBL · Class 2

All models of GN ReSound (106)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296201976), received between May 24, 2022 and May 24, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Temperature 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

Device problems

  • Temperature Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 24, 2022Temperature Problem; Temperature Problem

    KE361 DRW OVERHEATED AND BURNED PATIENT BEHIND HER LEFT EAR: THE SERIAL NUMBER IS (B)(4) AND IT DOES NOT COME UP CORRECTLY IN NAVISION. THIS HCP WAS CALLING IN ON BEHALF OF ANOTHER HCP IN THE OFFICE TO REPORT THIS SAFETY ISSUE. PT IS WEARING KE361 WITH 312 BATTERY AND SHE CALLED THE OFFICE TO SAY THAT SHE HAD NOTICED THE HEARING AID FELT WARM, TOOK IT OFF OF HER EAR, LET IT COOL, AND THEN PUT IT BACK ON, AND THEN NOTED THAT SHE HAD A BURN ON THE MASTOID AREA, BEHIND THE LEFT EAR. THE EXACT DATE IS UNKNOWN, PT REPORTED IT HAPPENING "AS FEW DAYS BEFORE HER APPOINTMENT", WHICH WAS ON (B)(6) 2022. AT THAT TIME, THE HCP TOLD HER TO STOP WEARING THE HEARING AID, WHICH THE PATIENT AGREED TO AS SHE WAS GOING TO UPGRADE TO A RT561. SHE WAS ALSO ADVISED TO SEEK MEDICAL TREATMENT, BUT SHE DID NOT. PT DID NOTE THAT SHE TREATED THE BURN WITH BACITRACIN OINTMENT. PT NOTED THAT SHE IS USING THE BATTERIES SUPPLIED TO HER BY (B)(6). PT WAS TO SEND THE HCP A PICTURE OF THE BURN, BUT THEY HAVE NOT RECEIVED IT. THE REPORTING HCP SAID THAT THE DISPENSING HCP DID NOT MAKE NOTE OF A BURN AT THE FOLLOW UP APPT ON (B)(6) 2022. THE HCP SAID THE PATIENT REPORTED THAT THE INCIDENT "HAPPENED A FEW DAYS BEFORE

    Patient problems: Burn(s)

    MAUDE report 14486121 ↗

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Sources and updates

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