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510(k) Data Aggregation

    K Number
    K963122
    Device Name
    UNITRON MODEL ICON KR
    Manufacturer
    UNITRON INDUSTRIES, INC.
    Date Cleared
    1996-09-06

    (25 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

    Behind-the-ear hearing aid. Substantially equivalent to other behind-the-ear hearing aids.
    Features: Three fitter controls Low Cut Tone, High Cut Tone, Threshold Knee-point. K-Amp circuit with Wide Dynamic Range compression. Class D circuits for excellent battery life. Telecoil with pre-amplifier.
    Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers
    Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987
    Fit: Hearing aid adjustment dictates by individual audiogram
    Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
    Power : Standard hearing aid battery - size 13.

    AI/ML Overview

    The provided document is a summary of safety and effectiveness information for a Unitron Industries hearing aid (ICON KR). It does not contain information about acceptance criteria, a study that proves the device meets those criteria, or any details related to AI or machine learning algorithms.

    Therefore, I cannot fulfill your request using the provided input. The document is an FDA 510(k) submission summary from 1996, focusing on the equivalence of a hearing aid to existing devices, technical specifications, and intended use, not on complex performance metrics or clinical study designs involving AI.

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