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GN ReSound 20556905Recalls & reported problems

Gn Hearing A/S · HI,ET598-DW,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 05708296086412), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Noise, Audible” (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

  • Noise, Audible1

Patient problems

  • Acoustic Shock1
  • Acoustic Trauma1
  • Dizziness1
  • Ear Pain1
  • Tinnitus1

Recent adverse event reports

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

  • InjuryMar 10, 2023Noise, Audible; Noise, Audible

    ON AN UNKNOWN DATE ((B)(6) 2023 BEST ESTIMATE) THE DEVICE "ZAPPED" THE HEARING CARE PROVIDER(HCP) WHEN SHE WAS DOING A SOUND CHECK.THE DEVICE WAS MALFUNCTIONING, INTERMITTENT AND POWER WAS LOW. THE HEARING AID WAS NOT ATTACHED BUT NEAR THE COUPLER. THE HCP REPORTED THAT IT EMITTED A SOUND THAT LITERALLY FELT LIKE IT PIERCED THE EARDRUMS AND FELT DIZZY AND ABOUT TO FAINT. ANOTHER HCP CHECKED HER RIGHT EAR AND SAID THERE WAS A FOG OVER TYMPANIC MEMBRANE (TM). ON (B)(6) 2023: THE HCP WENT TO AN AUTHORISED MEDICAL PRACTITIONER. THE MEDICAL PRACTITIONER FOUND SHE HAD EXPERIENCED ACOUSTIC TRAUMA TO BOTH EARS. IT CAN CREATE THE SENSATION SIMILAR TO THAT OF AN EAR INFECTION. A THICKENING OF THE INTERIOR WALL NEAR THE TM WAS REPORTED. THE HCP SYMPTOMS THE DAY OF THE APPOINTMENT WERE FULLNESS, PRESSURE, AND INCREASED TINNITUS IN BOTH EARS. A SORE FEELING THAT RESEMBLES WHAT AN EAR INFECTION WOULD OR COULD PRESENT. THE DECIDED LEVEL OF TREATMENT AT THIS TIME IS AN AGGRESSIVE 7 DAY STEROID IN PILL FORM. HCP IS GOING TO TAKE 3 PREDNISONE 20MG, 3 TIMES PER DAY OVER THE NEXT 7 DAYS IN THE MORNING WITH FOOD. THE MEDICAL PRACTITIONER STATES THE HCP COULD POTENTIALLY START TO FEEL BETTER IN AS SOON

    Patient problems: Acoustic Shock; Acoustic Trauma; Dizziness; Ear Pain; Tinnitus

    MAUDE report 16520662 ↗

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Sources and updates

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