GN ReSound 20357810Recalls & reported problems
Gn Hearing A/S · HI,LS961-DRW,SIL · 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 05708296074563), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface 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
- Human-Device Interface Problem1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2018Human-Device Interface Problem; Human-Device Interface Problem
PATIENT HAS DEVELOPED AN EAR INFECTION SHORTLY AFTER PURCHASING HER NEW HEARING AIDS.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7288549 ↗
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.
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