BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARKEY EVOLV AI HEARING AIDS

    MDR report key: 17010741 · Received May 25, 2023

    Report

    Report Number
    MW5117912
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 5, 2023
    Manufacturer
    STARKEY LABORATORIES, INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT THAT HIS STARKEY HEARINGS AIDS ARE UNSATISFACTORY DUE TO CONSISTENT BACKGROUND NOISE AND FAILURE OF HIS PROVIDER TO FOLLOW UP FOR PROPER SET-UP AND ADJUSTMENTS. PATIENT LEARNED THAT HE WAS GIVEN THE WRONG HEARING AIDS BY STARKEY AND WAS TOLD THAT THEY WOULD BE REPLACED FOR THE CORRECT HEARING AIDS BUT HAVE NOT HEARD BACK FROM THEM. HE PAID (B)(6) FOR THE HEARING AIDS AND HAS ATTEMPTED TO CONTACT HIS PROVIDER BUT HAS NOT HEARD BACK FROM THEM AND HIS INSURANCE COMPANY. STARKEY WILL NOT REIMBURSE HIM FOR THE DEVICES. PATIENT STATES THAT HE WOULD KEEP THE HEARING AIDS IF HE CAN GET A FOLLOW-UP APPOINTMENT FOR PROPER CARE, SET-UP AND ADJUSTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650211 STARKEY EVOLV AI HEARING AIDS HEARING AID, AIR-CONDUCTION, PRESCRIPTION ESD STARKEY LABORATORIES, INC. AI 2400

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male