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510(k) Data Aggregation

    K Number
    K130937
    Device Name
    WAVE 2G, SOUL
    Date Cleared
    2014-01-03

    (274 days)

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

    HANSATON AKUSTIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by hearing health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management. The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.
    Device Description
    The Hansaton Tinnitus Maskers are provided in two versions; the WAVE 2G, a noise generator intended to output noise for tinnitus habituation therapy and tinnitus masking therapy, and SOUL, a noise generator and hearing aid additionally providing amplification. Both, the WAVE 2G and the SOUL, systems are available as 'In The Ear' (ITE) and 'Behind The Ear' (BTE) versions.
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