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GN ReSound 21763000Recalls & reported problems

Gn Hearing A/S · PKG,CHGR STD,C-2,CFF2,HBM · Class 2

All models of GN ReSound (106)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708296215836), received between Aug 26, 2022 and Jul 17, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 reports).

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

  • Overheating of Device3
  • Material Discolored1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 17, 2023Overheating of Device; Overheating of Device

    ESTIMATED DATE OF INCIDENT (B)(6) 2023 (B)(6): ALTHOUGH IT WAS REPORTED AS A COMPLAINT- HEARING AIDS WON'T HOLD CHARGE, AND CHARGER INTERMITTENT. THE IMAGES OBTAINED OF THE DEVICE SHOWED A MELTED CHARGER PORT. THEREFORE THIS IS CASE IS ASSESSED AS REPORTABLE. IT IS UNKNOWN IF ORIGINAL GN ACCESSORIES WERE USED AT THE TIME OF INCIDENT. FURTHER FOLLOW UP IS ONGOING. (B)(6) FOLLOW UP RECEIVED (B)(6) 2023: ORIGINAL ACCESSORIES WERE USED AT TIME OF INCIDENT WARRANTY EXPIRATION (B)(6) 2024. NO FURTHER FOLLOW UP EXPECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17331809 ↗
  • MalfunctionJan 19, 2023Material Discolored; Overheating of Device; Use of Device Problem; Material Discolored; Overheating of Device; Use of Device Problem

    18-JAN-2023: IT WAS REPORTED THE CHARGER SHOWED SIGN OF HEAT AND THERE WAS DISCOLORATION NEAR CHARGING PORT. INCIDENT DATE WAS (B)(6) 2022. THE USER WAS NOT HARMED. ORIGINAL EQUITMENT WAS USED. THE REPLACEMENT DEVICE WAS PROVIDED TO THE PATIENT. (B)(6) 2023: NO FURTHER INFORMATION EXPECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16203129 ↗
  • MalfunctionAug 26, 2022Overheating of Device; Overheating of Device

    ON (B)(6) 2022: CHARGER PORT MELTED THE CORD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15299780 ↗

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Sources and updates

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