GN ReSound 22175673Recalls & reported problems
Gn Hearing A/S · HI,RU962-DRW,RIE,DP BLK · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296250158), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Positioning 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Positioning Problem1
Patient problems
- Skin Tears1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2023Positioning Problem; Positioning Problem
ON AN UNKNOWN DATE ON (B)(6), 2023 (BEST ESTIMATE), IT WAS REPORTED THAT A SORE DEVELOPED IN PATIENT'S EAR CANAL. PATIENT WAS FITTED WITH NEW RU962 AND HCP NOTED THAT THE OLD RECEIVERS HAD "RELAXED" AND HAD A LOOSER BEND INTO THE CANAL THAN THE NEW RECEIVER. PATIENT DID NOT WANT HER OLD RECEIVER ON THE NEW HEARING AID BECAUSE SHE STILL SWITCHED BETWEEN INSTRUMENTS. HCP USED A HAIR DRYER TO RELAX THE BEND. PATIENT IS A PHYSICIAN AND TREATED THE SORE WITH AN OINTMENT. AT A SUBSEQUENT VISIT, HCP SAID THE SORE IS HEALING WELL AND THE PATIENT WILL CONTINUE TO MONITOR. NO OTHER INJURY OR DAMAGE REPORTED. NO FURTHER INFORMATION IS EXPECTED.
Patient problems: Skin Tears
MAUDE report 17359370 ↗
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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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