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    K Number
    K962228
    Device Name
    MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
    Manufacturer
    OTOTECH INTL., INC.
    Date Cleared
    1996-08-28

    (79 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTOTECH INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ototech International Model Alpha Behind-The-Ear Hearing Instrument is intended for use by individuals with Moderate or Mild to Severe hearing loss.
    Device Description
    The Model Alpha is a linear hearing device. The electronics for this hearing instrument are contained in a custom acrylic plastic case. The device has one user control - the volume wheel, and no potentiometers. The device does not require any special fitting systems. The acoustical output of the Ototech Model Alpha is a maximum SSPL90 of 122 dB SPL (ANSI S3.22, 1987). The reference test gain is 43 dB SPL.
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