GN ReSound 20959905Recalls & reported problems
Gn Hearing A/S · HI,PZ862-DRW,BGE · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296160570), received between Jun 29, 2020 and Jun 29, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
AS REPORTED: PROGRAMMING PORT RUBBED SORE SPOT ON BACK OF EAR. UNSURE WHEN IT OCCURRED. HEARING DEVICE WAS NEW IN (B)(6) 2020 AND IS REPORTING ISSUE NOW. THE UNDERSIDE OF THE PREZA 62 DEVICE HAS THE RECTANGULAR CUT-OUT AREA FOR THE PROGRAMMING BOOT. THIS WOMAN HAS VERY THIN SKIN AND IT HAS RUBBED A SORE SPOT ON THE BACK OF HER EAR AND SHE WAS SEEN BY A PHYSICIAN FOR ANTIBIOTICS. THE STORE MEMBER REPORTS THAT THIS HAS HAPPENED TO THIS MEMBER IN THE PAST WITH OTHER BRANDS OF HEARING AIDS. HCP IS ASKING IF THERE IS A SPECIAL WORK REQUEST WERE WE COULD COVER UP THE RECTANGULAR OPENING TO MAKE THE BACK OF THE AID SMOOTH. MEMBER LIKES THE SOUND QUALITY OF THIS AID. MEMBER DOES NOT WANT THE PREZA RECHARGABLE WHICH IS SMOOTH. I TOLD HER I WILL NEED TO CHECK ON OPTIONS FOR MODIFYING THE CASE. I TALKED TO (B)(6) HER ISR ABOUT OPTIONS ALSO. COMPLAINT CREATED INTERPRETATION: THE UNDERSIDE OF THE PREZA 862 HAS A RECTANGULAR AREA CUT OUT FOR THE PROGRAMMING BOOT. THIS AREA HAS RUBBED A SORE SPOT. THE USER HAS A KNOWN HISTORY/WEAKNESS IN THIS AREA WITH OTHER HEARING AIDS. WE REPORT THIS EVENT AS A HCP HAS BEEN INVOLVED AND MEDICINE HAS BEEN PRESCRIBED. THERE'S STATED NO SIGN OF SCARRING, SO NO PE
Patient problems: Perforation
MAUDE report 10205206 ↗
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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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