BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUDIEN ATOM X HEARING AIDS

    MDR report key: 23368659 · Received October 23, 2025

    Report

    Report Number
    MW5177892
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 18, 2025
    Manufacturer
    AUDIEN /BUDGET HEARING AIDS LLC
    Product Code
    QUG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED AUDIEN ATOM X HEARING AIDS IN THE MAIL ON (B)(6) 2025. AFTER SUCCESSFULLY USING THEM (AND ADHERING TO THE INSTRUCTION MANUAL) I PUT THEM IN ON THE MORNING OF (B)(6) 2025. I NOTICED IMMEDIATELY THAT MY LEFT EAR FELT VERY HOT AND TOOK THE HEARING AID OUT. THE HEARING AID WAS HOT TO THE TOUCH. AFTER IT COOLED DOWN IT WAS NO LONGER WORKING. I CALLED CUSTOMER SERVICE AND RECEIVED INSTRUCTIONS TO SEND THEM BACK TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611882 AUDIEN ATOM X HEARING AIDS HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER QUG AUDIEN /BUDGET HEARING AIDS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female