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510(k) Data Aggregation

    K Number
    K971845
    Device Name
    HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
    Manufacturer
    SOUND HEARING INSTRUMENTS, INC.
    Date Cleared
    1997-08-15

    (88 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:
    X 1. Slight
    X 2. Mild
    X 3. Moderate
    X 4. Severe

    Configuration:
    X 1. High Frequency - Precipitously Sloping
    X 2. Gradually Sloping
    X 3. Reverse Slope
    X 4. Flat

    Other
    X 1. Low tolerance To Loudness

    Device Description

    To amplify and transmit sound to the ear.
    Assembled from standard components which are widely utilized by other hearing aid manufacturers.
    The frequency response of this product is dictated by the individual audiogram from each client.
    Standard hearing aid battery.
    A user's manual and other information is supplied with each hearing aid.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria, device performance results from a study, or details of a study methodology.

    The document is a US FDA 510(k) clearance letter for Heartland Technologies' ITE, ITC, and CIC hearing aids, dated August 15, 1997. It declares the device "substantially equivalent" to legally marketed predicate devices, allowing its commercialization.

    The letter mentions:

    • Intended Use: "To amplify and transmit sound to the ear."
    • Technical Characteristics: "Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications."
    • Fit: "The frequency response of this product is dictated by the individual audiogram from each client."
    • Indications for Use: General indications for individuals with impaired hearing across various severity levels (slight, mild, moderate, severe), configurations (high frequency - precipitously sloping, gradually sloping, reverse slope, flat), and "Low tolerance To Loudness."

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. The letter primarily focuses on regulatory clearance based on substantial equivalence, not on the detailed results of a performance study against specific acceptance criteria.

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