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510(k) Data Aggregation

    K Number
    K132965
    Device Name
    SOLACE SOUND GENERATORS
    Date Cleared
    2014-03-25

    (186 days)

    Product Code
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    **AMPLISOUND HEARING PRODUCTS **& SERVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Quell sound generators are designed for individuals who experience tinnitus. These devices generate a digitally controlled passive analog broad band noise from the circuit. The broad band noise is intended for use with tinnitus masking therapy. These devices are to be dispensed only by a doctor, licensed audiologist, or licensed hearing instrument specialist who are trained in the area of tinnitus treatment. BTE worn sound generators are one of several available sound stimuli means such as; computer generated audio, CD player, iPod, sound pillows, etc. Sound generators are dispensed to an adult population 18 years of age or above with specific instructions for their use.
    Device Description
    The Quell 908TD is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. These devices are programmable and offer the ability to adjust the frequency level of the masking sound to fit the individual user's needs. The programming can be done by hearing healthcare professionals using a standard HI-PRO box and Amplisound's Hearing Studio software. The Quell device resembles a miniature behind the ear (BTE) hearing aid. This style device sits on top of and just behind the pinna of the ear and has an acoustic soundtip connected to it. The soundtip is a removable and interchangeable tubing of different lengths, left and right, which carries the sound from the ear. The soundtip connects to the device at one end and bends around the front of the pinna to the other end which is connected to a dome tip which fits inside the ear canal. Quell devices operate on a hearing aid battery and have an easily operated user volume control wheel. The wearer adjusts the sound to a desired loudness level by rolling the volume wheel with a fingertip. Sound generators can be used for persons who suffer from tinnitus in conjunction with a sound therapy program such as Tinnitus Retraining Therapy (TRT). The sound therapy provides the tinnitus sufferer with an adjustable external sound source to mitigate the presence and annoyance of their personal internal noise. The Quell 908TD sound generator consists of a miniature digital amplifier and speaker powered by a 1.4 volt battery packaged inside a small hearing aid shaped housing and which generates a digitally adjustable broad band white noise. White noise is defined as noise containing many frequencies at similar intensities. The bandwidth is adjustable from the broadest range of 750Hz to 8KHz, to the narrowest of 1250Hz to 3850Hz. The broad band noise is delivered through a small tubing connected to the housing which curves around the pinna and then is placed inside the ear canal. This small tubing is called a 'soundtip' which comes in left and right sides in short, medium and long lengths. There is a small plastic locking handle which helps retain the device in the ear, and a replaceable open dome tip in 6, 8, 10mm sizes to help the tip be comfortable and well seated in the ear canal.
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