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510(k) Data Aggregation

    K Number
    K974338
    Device Name
    UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
    Manufacturer
    UNITRON INDUSTRIES, INC.
    Date Cleared
    1997-12-12

    (24 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

    The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

    Severity:

    1. Slight
    2. Mild
    3. Moderate
    4. Severe
    5. Profound

    Configuration:

    1. High Frequency -Precipitously Sloping
    2. Gradually Sloping
    3. Reverse Slope
    4. Flat
    5. Other

    Other:

    1. Low Tolerance to loudness
    Device Description

    Unitron Model Sound F/X Programmable Mini BTE Hearing Aid

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Unitron Model Sound F/X Programmable Mini BTE Hearing Aid. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a device that was on the market before May 28, 1976 (the enactment date of the Medical Device Amendments) or a device that has been reclassified.

    The focus of this type of submission is on demonstrating equivalence to an existing device, rather than providing a new study with specific acceptance criteria as might be seen for novel devices requiring Premarket Approval (PMA).

    Therefore, I cannot extract the requested information from the provided text. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts used for ground truth.
    4. Adjudication method.
    5. A multi-reader multi-case (MRMC) comparative effectiveness study.
    6. A standalone performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The only "indications for use" information provided (in page 3) is a general table outlining severity and configuration categories for hearing loss that the hearing aid is intended to address, which is not specific technical performance criteria.

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