GN ReSound 19368209Recalls & reported problems
Gn Hearing A/S · HI,LS777-DW,ANT2 · Class 2
Data updated Oct 13, 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 05704819256614), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Local Reaction1
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
WE HEREBY FORWARD A MIR REPORT RE. AN INCIDENT IN (B)(6) DUE TO WE SELL THE SAME DEVICE IN THE US. AS REPORTED BY LOCAL CUSTOMER SERVICE: POTENTIAL ALLERGIAL REACTION. ECZEMA IN THE OUTER EAR AND BEHIND THE EARS. USER IS ALLERGIC TO NICKEL, ACRYLIC, COBALT ETC.
Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Skin Irritation
MAUDE report 10835145 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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