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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOUND HEARING INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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