GN Hearing 20295000Recalls & reported problems
Gn Hearing A/S · EM,BTE-HA-TK · Class 2
Data updated Oct 13, 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 05708296140633), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Infectious Otitis Externa1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE USER EXPERIENCED DISCOMFORT WHICH GRADUALLY WORSENED TO PAIN, INFLAMMATION AND IRRITATION ON BOTH EARS OVER WEEKS TO MONTHS. THE USER SAW A MEDICAL PROFESSIONAL WHO DIAGNOSED THE USER WITH OTITIS EXTERNA AND PRESCRIBED ANTIBIOTICS AND STERIODS (FLOXACIN AND DEXAMETHASONE EAR DROPS, HYDROCORTISONE CREAM, AND MUPIROCIN OINTMENT) NO KNOWN HISTORY OF ALLERGIES, HYPERSENSITIVITIES OF FUNGAL INFECTIONS NO FURTHER FOLLOW UP IS EXPECTED.
Patient problems: Infectious Otitis Externa
MAUDE report 20461779 ↗
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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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