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510(k) Data Aggregation

    K Number
    K971807
    Device Name
    IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
    Manufacturer
    HEAR-RIGHT, INC.
    Date Cleared
    1997-08-07

    (84 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEAR-RIGHT, 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: Slight, Mild, Moderate, Severe, Profound. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other. Other: Low tolerance To Loudness.
    Device Description
    Not Found
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