GN Hearing 20293500Recalls & reported problems
Gn Hearing A/S · EM,USNC-HA-RF1-UP3P · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708296140480), received between Jun 21, 2024 and Jul 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ESTIMATED DATE OF INCIDENT (B)(6) 2024. IT WAS REPORTED THAT THE BRASS RING THAT HOLDS THE WAX FILTER IN PLACE, FELL OUT OF A NEW EARMOULD. NO HARM TO THE USER HAS BEEN REPORTED. FURTHER FOLLOW UP IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19781880 ↗MalfunctionJun 21, 2024Fracture; Fracture
ON 22MAY2024 IT WAS REPORTED THAT THE SHELL HAS CRACKED AND BROKEN OFF ON AN EARMOULD. NO HARM HAS BEEN REPORTED. 12JUL2024: DESPITE ATTEMPTS AT FOLLOW UP, NO FURTHER INFORMATION HAS BEEN RECEIVED. 15JUL2024: NO FURTHER FOLLOW UP EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582630 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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