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510(k) Data Aggregation

    K Number
    K964035
    Device Name
    PHONAK MICROLINK, PERSONAL FM RECEIVER
    Manufacturer
    PHONAK, INC.
    Date Cleared
    1996-12-04

    (57 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 receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.

    Device Description

    Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove meeting acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

    The document is a summary of safety and effectiveness information for the Phonak MicroLINK FM Receiver, likely from a regulatory submission (K964035 DEC - 4 1996). It describes the device's name, type, intended use, features, assembly, technical characteristics, and power source. It does not contain the detailed study results or methodological information you are requesting.

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