GN Hearing 21655100Recalls & reported problems
Gn Hearing A/S · EM,NC-HA-HPNG8 · Class 2
Data updated Oct 16, 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 05708296213368), received between Mar 19, 2026 and Aug 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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 Component2
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.
MalfunctionAug 27, 2026Detachment of Device or Device Component
It was reported that the brass riffel that hold the cerustop filter, fell out of the new encase mold on a hearing aid. The riffel fell out when the hearing care professional was replacing the user's wax guard and was not in the ear of the user. The object did not require removal and no harm was reported. This is an initial report. Further information is expected.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50473170 ↗MalfunctionMar 19, 2026Detachment of Device or Device Component
ESTIMATED DATE OF INCIDENT 01 FEB 2026. IT HAS BEEN REPORTED THAT THE WAX GUARD OF A NCASED EARMOULD IS NOT STAYING IN PLACE AND HAS BROKEN OFF INTO CX EAR. IT HAS NOT BEEN POSSIBLE TO CONFIRM WHAT CX REFERS TO, BUT MOST LIKELY IT REFERS TO 'CUSTOMER'. NO SYMPTOMS HAVE BEEN REPORTED. INITIAL SCREENING QUESTIONS ASKING IF THERE WAS ANY HARM TO THE USER, OR ANY POTENTIAL FOR HARM FOLLOWING THE INCIDENT HAVE BOTH BEEN ANSWERED WITH "NO". FURTHER FOLLOW UP IS REQUESTED. 17APR 2026. NO FURTHER FOLLOW UP FROM THE REPORTER RECEIVED. 13MAY 2026. NO FURTHER FOLLOW UP FROM THE REPORTER HAS BEEN RECEIVED, OR IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24636609 ↗
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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 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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