GN ReSound 19706502Recalls & reported problems
Gn Hearing A/S · HI,LT961-DRW,MBL · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05704819289612), received between Sep 14, 2020 and Sep 14, 2020 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Partial Hearing Loss1
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE LOCAL HEARING AID DEALER:LT961 LOUD STATIC AND PULSATING BEEPS.HCP REPORTS HE SENT IN A LT961 HA FOR REPAIR WITH COMPLAINT THAT THE HA WAS DEAD. HE SAID IT WAS REPLACED W/ SETTINGS SAVED, BUT NOW THERE WAS STATIC. ISSUE PERSISTED WITH A NEW RECEIVER, AND CALIBRATING THE HA. HA WAS RESTORED, AND ISSUE SEEMED RESOLVED. I HAD HIM TRY TO SAVE PREVIOUS SETTINGS TO SEE IF THE ISSUE PERSISTED. INITIALLY IT RESOLVED THE ISSUE, BUT AFTER A FEW MINUTES, THE STATIC BEGAN. WE RESTORED THE HA AGAIN TO START IN A BRAND NEW FILE AND RESET TO INITIAL FIT (NOT SAVE THE PREVIOUS SETTINGS), BUT AFTER THE RESTORE, THERE WAS LOUD STATIC AND LOUD QUICK PULSATING BEEPING. I RECOMMENDED THAT HCP REMOVE HA FROM PT'S EAR DURING RESTORE, BUT HCP LEFT HA IN PT'S EAR. PT REMOVED THE HA DUE TO THE LOUD SOUND (STATIC/BEEPS) AFTER THE RESTORE, BUT HCP REPORTED NO HARM. BEEPING STOPPED AFTER OPENING BATTERY DOOR. STATIC CONTINUED IN NEW NOAH FILE AFTER RESET TO INITIAL FIT. I HAD HIM TAKE THE RECEIVER FROM THE RIGHT HA THAT WAS FUNCTIONING PROPERLY, PUT ON THE LEFT SIDE, BUT THE ISSUE PERSISTED ON THE LEFT SIDE. HCP SENDING IN FOR REPAIR. I RECOMMENDED THAT THE REPAIRED HEARING AID BE RETURNED W
Patient problems: Partial Hearing Loss; Skin Irritation
MAUDE report 10526991 ↗
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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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