Skip to content

GN ReSound 21227300Recalls & reported problems

Gn Hearing A/S · HI,VA RE9MIH-W-UP · 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 05708296176533), received between Sep 2, 2020 and Sep 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • No Apparent Adverse Event1
  • Patient-Device Incompatibility1

Patient problems

  • Hearing Impairment1

Recent adverse event reports

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

  • InjurySep 2, 2020Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

    AS REPORTED BY CUSTOMER SERVICE: HEARING AID BACK FROM REMAKE AND SCREECHING. HAS NOT BEEN ABLE TO FIT HER PATIENT. FIRST THE AID WOULD NOT CONNECT, SHE SENT IT BACK AND NOW THE AID SCREECHES. INTERPRETATION BY CORPORATE QUALITY, PMS TEAM: THE PERCEIVED LOUD SOUND LEVEL OF THE DEVICE CAN POTENTIALLY HARM THE REMAINING HEARING OF THE PATIENT. NO INDICATIONS OF ANY SUCH HARM IS PROVIDED IN THE COMPLAINT, BUT IT CANNOT BE RULED OUT. THE DEVICE IS EQUIPPED WITH A ULTRA POWER RECEIVER.

    Patient problems: Hearing Impairment

    MAUDE report 10481501 ↗

Other Hearing aid, air conduction with wireless technology devices

All Hearing aid, air conduction with wireless technology devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page