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    K Number
    K965049
    Device Name
    DAHLBERG (A-554)
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-01-27

    (40 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K941121
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To amplify and transmit sound to the ear.

    Device Description

    BTE Hearing Aid

    AI/ML Overview

    This document describes an Audiotone A-554 BTE hearing aid, which is a Class I medical device. However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

    Therefore, I cannot fulfill your request for the detailed table and study information. The input focuses on the device's classification, intended use, technical characteristics (ANSI S3.22-1987 methodology for testing), and general specifications, but lacks the specific performance data and study details you've asked for.

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