GN ReSound 21211609Recalls & reported problems
Gn Hearing A/S · HI,RE561-DRW,ANT2 · 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 05708296178865), received between Sep 20, 2024 and Sep 20, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Explosion” (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.
Reports received per month
Most reported problems
Device problems
- Explosion1
Patient problems
- Burning Sensation1
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2024Explosion; Explosion
IT WAS REPORTED THAT A HEARING AID OVERHEATED AND EXPLODED (LOUD BANG) WHILE WEARING DEVICE IN EAR. USER REMOVED THE DEVICE AND SAW THE HOUSING WAS DISLOCATED AND THE DEVICE FELT VERY WARM. NO PHYSICAL HARM WAS REPORTED, NO INCREASE OF HEARING LOSS OR TINNITUS AS A RESULT OF THIS WAS REPORTED. THE USER HAS NOT SEEN A DOCTOR. HOT FEELING AND SCARRING (NO PHYSICAL HARM) WAS REPORTED. USER WAS WEARING THE HEARING AID DURING TRIAL PERIOD. WAS USING BATTERIES FROM VARTA CALLED POWER ONE EVOLUTION, WHICH WAS PROVIDED BY THE HEARING CARE PROVIDER. FURTHER INVESTIGATION TO BE CONDUCTED. 17-OCT-2024: DESPITE ATTEMPTS NO FURTHER FOLLOW UP INFORMATION RECEIVED.
Patient problems: Burning Sensation; Discomfort
MAUDE report 20264846 ↗
Other Hearing aid, air conduction with wireless technology devices
- GN ReSound 20472100Gn Hearing A/S · Hearing aid, air conduction with wireless technology55 reports
- GN ReSound 21625000Gn Hearing A/S · Hearing aid, air conduction with wireless technology20 reports
- Phonak Brand 050-0889-P5Sonova AG · Hearing Aid, Air Conduction With Wireless Technology8 reports
- 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 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page