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510(k) Data Aggregation

    K Number
    K103298
    Device Name
    ACAM 5 AUDIOMETER SYSTEM
    Manufacturer
    ACOUSTICON GMBH
    Date Cleared
    2011-04-08

    (151 days)

    Product Code
    EWO
    Regulation Number
    874.1050
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    Applicant Name (Manufacturer) :

    ACOUSTICON GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM), Hearing Instrument Test (HIT) and loudness scaling. ACAM 5 should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.
    Device Description
    ACAM® 5 is an audiometer with optional components for performing Real Ear Measurements (REM) Hearing Instrument Testing (HIT) and loudness scaling. It is intended to aid trained audiologists and hearing aid professionals in the diagnosis of hearing loss and the fitting of hearing aids. As a part of the REM and HIT modules ACAM performs several kinds of signal analysis including root mean squared (RMS), fast Fourier transformation (FFT) and percentile analysis (PA). ACAM® 5 gives an audiologist the ability to use one or any combination of the diagnostic tools recommended by the National Acoustics Laboratory (NAL) and Dr. Richard Seewald (DSL-IO). Available ACAM® 5 hardware consists of an audiometer with a modular control unit for peripheral components, which include a large or small hearing instrument test box and an in sity ear probe for real ear measurement. Headphones for audiometry, bone conduction and loudness scaling. loudspeakers, a microphone and an interrupter switch are available for use with the audiometer. ACAM®'s operational software meets the international software standards established by the Hearing Instruments Software Manufacturers Association (HIMSA) and the speech recognition standards (ISTS, International Speech Test Signals) established by the-European Hearing Instrument Manufacturers Association (EHIMA). The ACAM® 5 system meets or exceeds the following international standards: IEC 60645, ISO 8253, ISO 16832, ANSI S3.6, ANSI S3.22, EN 60118-0, EN 60118-7, DIN IEC 60118-15, ISO 12124, ANSI S3.43 ACAM® 5 should be operated by individuals with education and training in the field of audiology such as audiologists, hearing aid dispensers, health care and school nurses and ear nose and throat specialists.
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