GN ReSound 21197320Recalls & reported problems
Gn Hearing A/S · HI,EQ998-DWT,STRL GRY · 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 05708296178612), received between Jun 3, 2026 and Jun 3, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Battery 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.
Reports received per month
Most reported problems
Device problems
- Battery Problem1
Patient problems
- Caustic/Chemical Burns1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2026Battery Problem
IT WAS REPORTED THAT A USER EXPERIENCED A CHEMICAL BURN ON THE BACK OF HIS RIGHT EAR, AFTER A HEARING AID BATTERY LEAKED. THE USER WENT TO THE EMERGENCY ROOM AFTER EXPERIENCING THE BURN. IT IS UNKNOWN WHETHER ANY MEDICAL INTERVENTION WAS PRESCRIBED. DESPITE ATTEMPTS IT HAS NOT BE POSSIBLE TO OBTAIN FURTHER INFORMATION ON THIS COMPLAINT. NO FURTHER FOLLOW UP IS NOT AVAILABLE OR EXPECTED.
Patient problems: Caustic/Chemical Burns
MAUDE report 25374122 ↗
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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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