BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING

    MDR report key: 25121101 · Received May 8, 2026

    Report

    Report Number
    3005650109-2026-00010
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 7, 2026
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296210350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). MANUFACTURER'S INVESTIGATION: A DEVICE HISTORY RECORD REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. CLINICAL CONCLUSION: IT WAS REPORTED THAT A WAXGUARD HAD FALLEN OUT OF A RIGHT SIDE HEARING AID EARMOULD. THERE WAS NO HARM TO THE USER FOLLOWING THE INCIDENT, AS IT FELL OUT OUTSIDE OF THE EAR, WHILE ATTEMPTING TO CHANGE THE WAX GUARD. CLINICAL CONCLUSION ON THE EVENT IS THAT IT HAS NOT CAUSED HARM TO THE USER. HEARING AIDS NEED TO HAVE DETACHABLE SPARE PARTS AS WAX FILTERS. THEREFORE, ELIMINATING THE RISK OF A SPARE PARTS REMAINING IN THE EAR CANAL IS NOT POSSIBLE. A WAX FILTER CAN BECOME DETACHED AND REMAIN IN THE USER'S EAR CANAL WHEN THE HEARING AID IS REMOVED OR IF THE CERUSTOP BUSHING HAS BECOME DISLODGED FROM EXCESSIVE FORCE APPLIED DURING REPLACEMENTS OR CLEANING OF THE WAX FILTER. WITHOUT BUSHING, A REPLACED CERUSTOP IS NOT SECURE AND MAY FALL OUT IN THE EAR. THE WAX FILTER THEN CONSTITUTES A FOREIGN BODY IN THE EAR CANAL AND SHOULD BE REMOVED AS SOON AS POSSIBLE AS IT CAN POSE AN INFECTION RISK. ADDITIONALLY, SKIN REACTIONS CAN OCCUR IF IMPROPER CLEANING SUPPLIES ARE BEING USED ON THE DEVICES. SOME CLEANING AND DRYING PRODUCTS CONTAIN ALCOHOL AND CHEMICALS THAT CAN CAUSE SKIN IRRITATION OR ALLERGIC REACTIONS. IN ADDITION, THE CHEMICALS CAN DAMAGE THE MATERIAL, POTENTIALLY RESULTING IN A RAW SURFACE THAT CAN LEAD TO SKIN IRRITATION FROM A RASH. AS THE DEVICES ARE PHYSICALLY TOUCHING THE EAR/EAR CANAL THERE ARE RISKS OF INFECTION IN CASES WHERE THERE WAS CONTAMINATED HANDLING OFTEN DEVICES OR IMPROPER CLEANING, SHOULD A DETACHABLE PORTION OF THE HEARING AID (E.G., DOME, WAX FILTER) BECOME LODGED IN THE EAR CANAL, OR AS, ABOVE, A DAMAGED DEVICE CAUSING CUTS/SCRATCHES TO THE EAR RESULTING IN INFECTION. THE HAZARD IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED ON DEVICE DESIGN BY ENSURING THAT THE WAX FILTER CANNOT BE REMOVED WITHOUT A TOOL. THE USER GUIDE INCLUDES AN INSTRUCTION ON HOW TO REPLACE A WAX FILTER WITH A TOOL AND TO CONTACT THE HEARING CARE PROFESSIONAL (HCP) IF A FOREIGN OBJECT IS LOCATED IN THE EAR CANAL. RISK ASSESSMENT: RISKS RELATED TO OBJECTS GETTING STUCK IN THE EAR CANAL ARE GENERALLY KNOWN, CONSIDERED IN THE RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THE RISK IS DEEMED TO BE OF AN ACCEPTABLE NATURE. DEVICE INVESTIGATION CONCLUDED: VISUAL INSPECTION CONFIRMS WAX GUARD GROMMET IS MISSING. VENT IS CLEAR. INSERT FOR RECEIVER BODY IS IN PROPER POSITION AND SECURE. THE GROMMET THAT FELL OUT WAS NOT SENT IN WITH THE EARMOLD FOR INVESTIGATION. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WAXGUARD HAD FALLEN OUT OF A RIGHT SIDE HEARING AID EARMOULD. THE WAX GUARD FELL OUT OUTSIDE OF THE EAR, WHILE ATTEMPTING TO CHANGE THE WAX GUARD. THERE WAS NO HARM TO THE USER FOLLOWING THE INCIDENT. NO FURTHER FOLLOW UP IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580157 GN HEARING HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21654600 05708296210350

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male