GN Hearing 22015875Recalls & reported problems
Gn Hearing A/S · HI,PM861-DRWC,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 05708296221974), received between Apr 4, 2024 and Apr 4, 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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component
DATE OF INCIDENT: (B)(6) 2024 IT WAS REPORTED THAT A SMALL POWER DOME BROKE AWAY FROM WIRE AND ENDED UP IN MEMBERS EAR ON (B)(6) 2024. PROVIDERS SENT MEMBER TO PHYSICIAN FOR REMOVAL AS PIECE WAS SIDEWAYS AND THEY HAD NO OPTIONS FOR REMOVAL. THE OBJECT WAS REMOVED FROM EAR BY PHYSICIAN AND THERE IS NO DAMAGE TO THE EAR CANAL. NO FURTHER INFORMATION IS EXPECTED. THERE WAS NO HARM TO THE USER AS A RESULT OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040691 ↗
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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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