BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENIRE

    MDR report key: 18970171 · Received March 22, 2024

    Report

    Report Number
    MW5153093
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    November 14, 2023
    Report Date
    March 20, 2024
    Manufacturer
    NEUROMOD DEVICES LIMITED
    Product Code
    QVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I'VE HAD TINNITUS FOR ABOUT 4 YEARS AND RECENTLY I READ ABOUT A MEDICAL DEVICE THAT WAS SUPPOSED TO LESSEN THE SOUND OF TINNITUS, THOUGH THERE WAS NO GUARANTEE. THE MEDICAL DEVICE IS FROM THE MANUFACTURER, NEUROMOND AND THE DEVICE IS LENIRE AND WAS FDA APPROVED LAST YEAR. IT CONSISTS OF HEADPHONES AND A TONGUE PAD THAT EMITS A VERY MILD BUZZ ON THE TONGUE. THE DEVICE HAS A CONTROL BOX THAT EMITS A SERIES OF SOUNDS INTO THE HEADPHONES. MY TINNITUS HAS GOTTEN SO MUCH LOUDER AND HIGHER PITCHED THAT I HAD TO SEEK CARE WITH A SPECIALIST IN TINNITUS CARE, A PSYCHOLOGIST. I USED THE DEVICE FOR ALMOST 2 MONTHS AND I TOLD THE AUDIOLOGIST AFTER 6 WEEKS USE THAT THE TINNITUS WAS WORSE AND SHE SAID INCREASE IN SOUND OF THE TINNITUS SOMETIMES HAPPENS BUT IT WILL GET BETTER. AT THE END OF 6 WEEKS THE TINNITUS WAS EVEN LOUDER AND I QUIT USING IT. I HAVE NO IDEA HOW MANY PEOPLE ARE HAVING THIS PROBLEM WITH THE DEVICE TREATMENT BUT TO ME IT HAS SERIOUSLY AFFECTED MY QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408708 LENIRE COMBINED ACOUSTIC AND ELECTRICAL EXTERNAL STIMULATION DEVICE FOR THE RELIEF OF T QVN NEUROMOD DEVICES LIMITED CR-201 0 5391540582015

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female