GN Hearing 22850175Recalls & reported problems
Gn Hearing A/S · HI,EP260S-C,RIE,CHMPN · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296315956), received between May 23, 2024 and May 23, 2024 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Product Quality Problem1
Patient problems
- Unspecified Ear or Labyrinth Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component
T WAS REPORTED THAT ON THE (B)(6) 2024 THE USER CALLED BECAUSE SHE HAD BEEN REPORTING FEEDBACK & INTERMITTENCY WITH THE LEFT AID. WHEN THE EAR WAS EXAMINED IT WAS DISCOVERED THAT THERE WAS A DOME IN THE EAR CANAL. THE USER HAD TO BE REFERRED TO MEDICAL FACILITY TO GET THE DOME REMOVED. NO HARM TO THE USER HAS BEEN REPORTED. NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: Unspecified Ear or Labyrinth Problem
MAUDE report 19380247 ↗
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- 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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