BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONICS OASIS TINNITUS TREATMENT

    MDR report key: 2830170 · Received November 6, 2012

    Report

    Report Number
    MW5027564
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    May 15, 2012
    Report Date
    November 6, 2012
    Manufacturer
    NEUROMONICS
    Product Code
    KLW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SUBJECT: NEUROMONICS - OASIS TREATMENT FOR TINNITUS SUFFERERS. THIS DEVICE EXACERBATED THE TINNITUS AND IT HAS NEVER RETURNED TO PREVIOUS LEVEL. IT WAS PRESCRIBED BY DR (B)(6) OF (B)(6). (B)(6) HAS SUFFERED UNTOLD AGONY FROM THE EXACERBATION OF THE TINNITUS NOISE CAUSED BY THIS DEVICE. IT HAS BEEN RETURNED TO THE COMPANY, NEUROMONICS, INC. AND MONEY HAS BEEN REFUNDED FOR THE DEVICE ITSELF, BUT NOT FOR PHYSICIAN CHARGES. THIS REPORT IS BEING FILED TO HOPEFULLY PREVENT SOMEONE ELSE FROM BECOMING A VICTIM TO THIS MEDICAL. NEUROMONICS NON-INVASIVE DEVICE, CUSTOMIZED TO EACH PT'S INDIVIDUAL AUDIOLOGICAL PROFILE, DELIVERS A NEURAL STIMULUS THAT TARGETS THE BRAIN'S AUDITORY PATHWAYS. CLINICALLY ADMINISTERED AND MONITORED, THE TREATMENT IS A THERAPY DELIVERED THROUGH A COMPACT, LIGHTWEIGHT DEVICE. TARGETING THE NEUROLOGICAL PROCESSES OF TINNITUS - SPECIFICALLY ITS AUDIOLOGICAL, ATTENTION-BASED AND EMOTIONAL ASPECTS. NTT TYPICALLY OCCURS OVER AN APPROX SIX-MONTH PERIOD, WITH DAILY USE RECOMMENDED FOR TWO OR MORE HRS PER DAY. RESEARCH PUBLISHED IN THE APRIL 2007 ISSUE OF EAR AND HEARING DEMONSTRATES THAT THE TREATMENT YIELDS CLINICALLY SIGNIFICANT REDUCTION IN TINNITUS DISTURBANCE FOR MORE THAN 90 PERCENT OF SUITABLE PTS. WEAR 4 - 6 HRS PER DAY. DATES OF USE: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONICS OASIS TINNITUS TREATMENT OASIS KLW NEUROMONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| S