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GN ReSound 20585408Recalls & reported problems

Gn Hearing A/S · HI,FT888-DWH,BLK · 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 05708296088645), received between Oct 13, 2020 and Oct 13, 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

  • Local Reaction1
  • Skin Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    AS REPORTED BY THE LOCAL SALES OFFICE: RIGHT HEARING AID GETS REALLY HOT ON PT'S EAR. MEMBER AIDS GET HOT IN THE EARS WHEN ON THE PHONE. MEMBER HAD DEVICE FOR 2 YEARS AND 5 MONTHS. MEMBER HAD SMALL RASH IN MIDDLE OF CANAL. STARTED ONE MONTH BEFORE DEVICE SENT IN FOR REPAIR MEMBER WENT TO DERMATOLOGY FOR CREAM. MEMBER NO LONGER HAVE RASH (NO SCARRING). MEMBER WENT TO ENT. ENT SUGGESTED TO NOT WEAR THE HEARING AIDS FOR FEW WEEKS TELL THE RASH GONE.

    Patient problems: Local Reaction; Skin Irritation

    MAUDE report 10669836 ↗

Other Hearing aid, air conduction with wireless technology devices

All Hearing aid, air conduction with wireless technology devices →

Sources and updates

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