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 ↗
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- GN Hearing 21655200Gn Hearing A/S · Hearing aid, air conduction with wireless technology8 reports
- Beltone 20623200Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- Beltone 21625700Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- GN Hearing 20863700Gn Hearing A/S · Hearing aid, air conduction with wireless technology5 reports
- Phonak Audéo I90-Sphere (graphite gray)Sonova AG · Hearing Aid, Air-Conduction With Wireless Technology, Prescription5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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