GN ReSound 19706702Recalls & reported problems
Gn Hearing A/S · HI,LT561-DRW,MBL · Class 2
All models of GN ReSound (106)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819289896), received between Jun 26, 2020 and Jun 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Hearing Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED: LOUD STATIC ON LT 561. HEARING AID HAS BEEN IN FOR REPAIR 3 TIMES, AND CONTINUES TO GIVE THE PATIENT PROBLEMS. THERE IS VERY LOUD STATIC, AND THE PATIENT HAS RESULTED IN NOT WEARING THE AIDS. LOUD STATIC SOUND COMING FROM HEARING AID. IT HAPPENS WHEN THE PATIENT IS AT HOME, AND IT ALSO HAPPENS WHEN HE'S OUTSIDE. IT ALSO HAPPENED IN THE AUD'S OFFICE AS WELL. IT WOULD HAPPEN SPORADICALLY. VERY LOUD STATIC. OUR CUSTOMER CAN HEAR IT WHEN THE HEARING AID IS LAYING ON THE COUNTER. PATIENT SAID THE SOUND "DRIVES HIM CRAZY" AND HE HAS TO PULL OUT THE HEARING AID BECAUSE IT'S TOO LOUD. INTERPRETATION: THE LOUD STATIC SOUND CAN POTENTIALLY HARM THE REMANINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. THIS IS A FOLLOW-UP / THE FINAL REPORT.
Patient problems: Hearing Impairment
MAUDE report 10199578 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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