GN ReSound 20661405Recalls & reported problems
Gn Hearing A/S · HI,LT961-DRWZ,BGE,US · 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 05708296095087), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
InjuryApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(6) 2023. ON SATURDAY ((B)(6) 2023) PATIENT WENT TO COSTCO LOOKING TO PURCHASE NEW AIDS. WHEN THEY DID AN EAR EXAM THEY DISCOVERED A DOME LODGED IN HIS LEFT EAR AND SUGGESTED HE GO TO URGENT CARE FOR REMOVAL. HE IMMEDIATELY WENT TO URGENT CARE AND THEY REMOVED THE DOME. A PHYSICIAN AND TECHNICIAN AT PATIENT FIRST (URGENT CARE) REMOVED THE DOME WITH INSTRUMENTS. PATIENT SAYS HE HADN'T BEEN WEARING HIS AIDS FOR SOME TIME BECAUSE HE THOUGHT THEY WERE FAULTY AND IS NOW CONVINCED THIS IS THE PROBLEM FOR HIS INCREASED HEARING LOSS. DEVICE IS OVER A YEAR OUT OF WARRANTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760622 ↗
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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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