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510(k) Data Aggregation

    K Number
    K970692
    Device Name
    UNITRON MODEL SOUND F/X CIC
    Manufacturer
    UNITRON INDUSTRIES, INC.
    Date Cleared
    1997-05-08

    (72 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 amplify and transmit sound via air conduction to the ear.

    Device Description

    Completely-In-The-Canal Hearing Aid. Substantially equivalent to other Completely-In-The-Canal hearing aids. Features: Two channel wide dynamic range compression. Six adjustable parameters: Low-channel Gain, High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point and power. Twin average compression detectors. Class D Circuitry for excellent battery life. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Controls: Screw set Volume Control, similar to other CIC devices. Power: Standard hearing aid battery - size 10A or 5A. A user's manual and other information is supplied with each hearing aid.

    AI/ML Overview

    This document is a summary of safety and effectiveness information for a hearing aid from 1997. It describes the device's features and technical specifications but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    Therefore, I cannot provide the requested information. The document focuses on describing the device itself and its equivalence to other devices, rather than presenting a performance study against specific acceptance criteria.

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