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510(k) Data Aggregation

    K Number
    K960741
    Device Name
    COMFORTONE PHS
    Manufacturer
    COMFORTONE AMERICA'S VALUE HEARING AID LINE
    Date Cleared
    1996-05-07

    (74 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To amplifiy and transmit sound to the ear.

    Device Description

    In The Ear Hearing Aid - Substantially equivalent to other In The Ear (ITE) hearing aids. Controls volume, gain, peak clipper, AGC, kneepoint low frequency out and high frequency out as appropriate. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications, Preliminary data sheets for the PHS models are enclosed. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.

    AI/ML Overview

    The provided text describes a hearing aid device (COMFORTONE PHS HEARING AID) and its general characteristics. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

    Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and reported performance, nor can I answer questions 2 through 9 regarding study methodology, sample sizes, ground truth establishment, or expert involvement. The document is primarily a descriptive summary of the device for regulatory submission (K960741), not a study report.

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