BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEXIE B2 HEARING AIDS

    MDR report key: 18266942 · Received December 4, 2023

    Report

    Report Number
    MW5148756
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 1, 2023
    Manufacturer
    HEARX USA
    Product Code
    QUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE OWNED A PAIR OF LEXIE B2 HEARING AIDS FOR A YEAR. THEY CONSTANTLY SCREECH, ESPECIALLY WHEN I AM TALKING. PEOPLE HEAR THE SCREECH. I HAVE ASKED LEXIE TO FIX THEM AND THEY SENT A REPLACEMENT WIRE BUT THE PROBLEM PERSISTS. IN ADDITION, MY INNER EAR STARTED TO ITCH WHEN USING THE HEARING AIDS THIS THANKSGIVING WHICH IS AN ADVERSE EVENT. FURTHERMORE, ANOTHER ADVERSE EVENT OCCURRED WHEN ONE OF THE TIPS BECAME STUCK IN MY EAR CANAL FOR A BRIEF MOMENT, ALTHOUGH I WAS ABLE TO REMOVE IT. THESE HEARING AIDS OMIT A LOUD SCREECHING NOISE AND NOW HAVE STARTED TO CAUSE DAMAGE TO MY EAR CANAL AND ARE ESSENTIALLY UNWEARABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177800 LEXIE B2 HEARING AIDS SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER QUH HEARX USA BMD014

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Other