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510(k) Data Aggregation

    K Number
    K150171
    Device Name
    Tinnitus Sound Generator Module
    Manufacturer
    GN RESOUND A/S
    Date Cleared
    2015-05-14

    (108 days)

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

    GN RESOUND A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Timitus Management Program to relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
    Device Description
    The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device in all environments. The fitting of the digital device, which contains the Timitus Sound Generator module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient. A mobile medical application (app) is available as an accessory to the Tinnitus Sound Generator. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Control App.
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    K Number
    K110932
    Device Name
    TINNITUS SOUND GENERATOR MODULE
    Manufacturer
    GN RESOUND A/S
    Date Cleared
    2011-05-03

    (29 days)

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

    GN RESOUND A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. The Tinnitus Sound Generator Module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator Module must be done by a hearing professional participating in a Tinnitus Management Program.
    Device Description
    The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device all day in all environments. The fitting of the digital device, which contains the Tinnitus Sound Generator Module, is performed by a healthcare professional, in order to meet the exact needs of the tinnitus patient.
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    K Number
    K073636
    Device Name
    TINNITUS SOUND GENERATOR MODULE
    Manufacturer
    GN RESOUND A/S
    Date Cleared
    2008-03-13

    (78 days)

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

    GN RESOUND A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a tinnitus management program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound generator module must be done by hearing professional participating in a tinnitus management program.
    Device Description
    The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provide relief for tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device all day in all environments. The fitting of the mistrations portions, so that the sound generator module is fitted by a healthcare professional to fit the exact needs of the tinnitus patient.
    Ask a Question

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