BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITRON HEARING AIDS

    MDR report key: 21677684 · Received March 24, 2025

    Report

    Report Number
    MW5168028
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Report Date
    March 17, 2025
    Manufacturer
    UNITRON HEARING, A DIVISION OF NATIONAL HEARING SERVICES INC.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HEARING GOT WORSE AFTER USING UNITRON HEARING AIDS. WHEN I TAKE THEM OUT IT IS LIKE I AM UNDERWATER. WHEN I ASK THEM ABOUT IT THEY JUST SAY IT IS MY BRAIN READJUSTING WITH NERVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718871 UNITRON HEARING AIDS HEARING AID, AIR-CONDUCTION, PRESCRIPTION ESD UNITRON HEARING, A DIVISION OF NATIONAL HEARING SERVICES INC. MAXI-V-R

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female LISINOPRIL.| VITAMIN B12.| VITAMIN D3.