GN Hearing 19443200Recalls & reported problems
Gn Hearing A/S · EM,NC-HA-RF1-UP3P · Class 2
Data updated Oct 16, 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 05708296140824), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DESCRIPTION OF EVENT FROM INITIAL REPORTER: PATIENT SYMPTOM: INFECTION IN BOTH EARS, OOZING. THE FITTING PROCESS ENDED UP IN DECEMBER; THE PATIENT HAS WORN THE MOLDS SINCE THEN (APPROX. FIVE AND A HALF MONTHS). THE SKIN REACTION / INFECTION HAS BEEN CONFIRMED BY DOCTOR. ACCORDING TO THE INFORMATION PROVIDED BY THE HEALTH CARE PROFESSIONAL, THE REACTION DOES NOT SEEM TO BE CAUSED BY WEARING THE DEVICES IN A SPECIFIC ENVIRONMENT. THE PATIENT USES A CLEANING AGENT: HADEO CLEANING SPRAY. THE PATIENT HAS WORN HEARING INSTRUMENTS BEFORE (RIE HI + DOME). ADDITIONAL INFORMATION PROVIDED IN THE QUESTIONNAIRE: ACCORDING TO THE INFORMATION PROVIDED BY THE HEALTH CARE PROFESSIONAL, THE SYMPTOMS REAPPEAR WHEN THE PATIENT WEARS THE INSTRUMENTS AGAIN. NO PERMANENT HARM HAS BEEN CAUSED YET DESPITE THE PATIENT, BEING INFORMED OF THE RISK, CONTINUES TO WEAR THE HEARING INSTRUMENT WITH THE MOLDS FOR LIMITED PERIODS OF TIME. THE OCCLUSION PRODUCES A DAMP ENVIRONMENT IN THE EAR THAT CAUSES INFECTION. PRESCRIPTION: DRYOTIX, A SPRAY TO REMOVE THE EXCESS MOISTURE FROM THE EAR AND THAT HELPS PREVENTING OTITIS AND OTHER EAR INFECTIONS. ADDITIONAL INFORMATION PROVIDED ON 27MAY2021: THE INFORMATION RECEIVED T
Patient problems: Unspecified Infection
MAUDE report 12503830 ↗
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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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