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510(k) Data Aggregation

    K Number
    K970519
    Device Name
    UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
    Manufacturer
    UNITRON INDUSTRIES, INC.
    Date Cleared
    1997-04-24

    (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

    Sound F/X Programmable In-The-Ear Programmable Hearing Aid. Five programmable parameters: Low-channel Gain, High-channel Gain, Cross-over Frequency, Threshold Kneepoint, Power. Two channels with wide dynamic range compression circuitry independently adjustable for each channel. 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. Volume Control, similar to other devices. Standard hearing aid battery size 13, 312 or 10A.

    AI/ML Overview

    This document is a 510(k) summary for the Unitron Industries Sound F/X Programmable In-The-Ear Programmable Hearing Aid, dated April 24, 1997. It describes the device's intended use, features, and technical characteristics. However, it does not contain any information regarding clinical studies, acceptance criteria, or performance data.

    Therefore, I cannot provide the requested information, which includes:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. Method for establishing ground truth for the training set.

    The document is purely a descriptive summary of the hearing aid's technical specifications and intended use for regulatory clearance, not a study report.

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