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GN ReSound 19706708Recalls & reported problems

Gn Hearing A/S · HI,LT561-DRW,BLK · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819289933), received between Sep 20, 2022 and Sep 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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

  • Overheating of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 20, 2022Overheating of Device; Overheating of Device

    SF: (B)(4). IT WAS REPORTED- AIDS PUT IN DRY JAR AND MELTED. CUSTOMER VERIFIED THE JAR WAS NOT RESOUND BRAND. THEY BELIEVE THE HEAT ELEMENT IN THE JAR CAUSED THE MELTING AND THEREFORE WAS NOT RELATED TO THE RESOUND AIDS, BUT NO SPECIFIC INVESTIGATION WAS DONE' THE CURRENT INFORMATION INDICATES NEED FOR IMMEDIATE REPORTING. BASED ON THE AVAILABLE INFORMATION, THE EVENT/ INCIDENT DID LEAD TO, OR MIGHT LED TO, DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THIS IS AN INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15452954 ↗

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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