BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEAR XPLORE OTC RECHARGEABLE RECEIVER IN THE CANAL HEARING AID KIT - HEARING A

    MDR report key: 19498664 · Received June 7, 2024

    Report

    Report Number
    MW5155989
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Report Date
    June 6, 2024
    Manufacturer
    IHEAR DIRECT
    Product Code
    QUF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 I PLACED AN ON LINE ORDER (B)(4) FOR THE IHEAR XPLORE OTC CANAL HEARING AID KIT (B)(6) THROUGH CVS, OUR PHARMACY FOR MEDICAL AND HEALTH PRODUCTS. THE PRODUCT ARRIVED (B)(6) 2024 AND WAS AVAILABLE FOR MY USE UNTIL (B)(6) 2023 WHEN THE CHARGING BOX WAS NOT CHARGING PROPERLY. AFTER CONTACTING THE COMPANY I WAS ABLE TO RETURN IT (ORDER (B)(4)) FOR A REPLACEMENT CHARGER AT NO COST. RECENTLY I BEGAN EXPERIENCING ISSUES WITH FEEDBACK IN THE LEFT AID AND ISSUES ADJUSTING VOLUME IN THE RIGHT AID. I INITIALLY CONTACTED CVS AND THEY ADVISED THEIR WAS NOTHING THEY COULD OFFER FOR AN OTC PRODUCT. I THEN TRIED ON A NUMBER OF OCCASIONS TO REACH THE COMPANY AND NEVER HEARD BACK. THEIR WEB SITE ONLY HAS A LOGO PAGE. COMPANY WEBSITE: IHEARDIRECT.COM. SERIAL NUMBER: (B)(6) LEFT; SERIAL NUMBER: (B)(6) RIGHT; LOT NUMBER: 22P13922.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608455 IHEAR XPLORE OTC RECHARGEABLE RECEIVER IN THE CANAL HEARING AID KIT - HEARING A HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF IHEAR DIRECT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown