GN ReSound LT9ITE-DW-HPRecalls & reported problems
Gn Hearing A/S · HI,RS LT9ITE-DW-HP · 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 05708296142668), received between Nov 30, 2022 and Nov 30, 2022 — classified as 1 malfunction.
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 18, 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.
MalfunctionNov 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ON 19-DEC-2022: NO FURTHER INFORMATION IS EXPECTED. ON (B)(6) 2022: USER HAD HEARING AIDS REPAIRED IN AUGUST. AROUND (B)(6) 2022 (BEST ESTIMATE PROVIDED) USER CAME IN WITH FOUR WAXGUARDS IN LEFT EAR THAT HAD FALLEN OUT OF THE HEARING AID ON THE LEFT SIDE. THE USER STATES THAT IT HAD NOT BEEN RIGHT SINCE THE REPAIR, AND WOULD LIKE IT REPAIRED WITHOUT CHARGE. THE HEARING AID IS MISSING BRASS RING THAT HOLDS THE WAXGUARD IN. THE WAXGUARDS WERE REMOVED BY A HEALTH CARE PROFESSIONAL, AND NO HARM TO USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15884416 ↗
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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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