GN ReSound 21303874Recalls & reported problems
Gn Hearing A/S · HI,RT761-DRWC,BRNZ · 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 05708296194568), received between Jul 15, 2022 and Jul 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Unintended Electrical Shock1
Patient problems
- Electric Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2022Insufficient Device Problem Information; Unintended Electrical Shock; Insufficient Device Problem Information; Unintended Electrical Shock
AROUND (B)(6) 2022 THE PATIENT'S FRIEND NOTICED A FLASHED BRIGHT LIGHT, SPARK IN THE PATIENT'S EAR CANAL, AND THE PATIENT EXPERIENCED AN ELECTRIC/STATIC SHOCK. THE PATIENT HAVE NOT BEEN IN CONTACT WITH AN AUTHORIZED MEDICAL PRACTITIONER.
Patient problems: Electric Shock
MAUDE report 15025977 ↗
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- 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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