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GN ReSound LT5ITE-DW-UPRecalls & reported problems

Gn Hearing A/S · HI,RS LT5ITE-DW-UP · Class 2

All models of GN ReSound (106)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296141784), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem1

Patient problems

  • Partial Hearing Loss1
  • Skin Irritation1

Recent adverse event reports

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

  • MalfunctionSep 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    AS REPORTED BY THE LOCAL HEARING AID DEALER: LOUD SQUAWKING NOISE. THIS HEARING AID WAS SENT IN (B)(6) 2020. IT WAS RETURNED TO THE PATIENT. WHEN SHE WAS SEEN FOR CONCERNS WITH THE LEFT HEARING AID, SHE REPORTED THAT SHE HAS TO TURN IT DOWN WHEN IT SQUAWKS. A LISTENING CHECKED SEEMED FINE. BUT WHEN THE PATIENT WAS SITTING THERE, SHE SAID "THERE IT GOES," AND, THIS VERY LOUD SQUAWKING NOISE OCCURRED - I COULD HEAR IT. NOT FEEDBACK. THEN, I TOOK IT, OPENED THE DOOR, IT WAS FINE FOR A COUPLE MINUTES THEN IT STARTED AGAIN. IT IS VERY NOISE, AND HONESTLY, QUITE ANNOYING. PLEASE FIX SO# 10-C559618. COMMENT BY CORPORATE QUALITY: THIS IS A ULTRA POWER HEARING AID. NO HARM HAS BEEN CLAIMED, BUT WE HAVE CURRENTLY NOT RECEIVED THE SAMPLES, SO WE CAN TEST IF IT HAS MALFUNCTIONED. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

    Patient problems: Partial Hearing Loss; Skin Irritation

    MAUDE report 10605337 ↗

Other Hearing aid, air conduction with wireless technology devices

All Hearing aid, air conduction with wireless technology devices →

Sources and updates

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