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
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- GN Hearing 21655200Gn Hearing A/S · Hearing aid, air conduction with wireless technology8 reports
- Beltone 20623200Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- Beltone 21625700Gn Hearing A/S · Hearing aid, air conduction with wireless technology7 reports
- GN Hearing 20863700Gn Hearing A/S · Hearing aid, air conduction with wireless technology5 reports
- Phonak Audéo I90-Sphere (graphite gray)Sonova AG · Hearing Aid, Air-Conduction With Wireless Technology, Prescription5 reports
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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