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    K Number
    K973043
    Device Name
    MODEL C-1 HEARING AID
    Manufacturer
    BETTER HEARING, INC.
    Date Cleared
    1997-10-27

    (73 days)

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

    BETTER HEARING, 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: 1. Slight 2. Mild 3. Moderate 4. Severe 5. Profound Other Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other 1. Low tolerance To Loudness
    Device Description
    BETTER HEARING, INC. model C-1 Hearing Aid, Type: Behind-The-Ear (BTE), Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300. Manufactured from materials commonly used in the industry. Hearing Aid has been tested per ANSI S3.22 1987. Fits: Mild to moderate hearing losses. Power: Size 675 Battery
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    K Number
    K971298
    Device Name
    BETTER HEARING, INC. MODEL L-1 HEARING AID
    Manufacturer
    BETTER HEARING, INC.
    Date Cleared
    1997-07-23

    (107 days)

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

    BETTER HEARING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To amplify and transmit sound to the ear. 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): Severity: Severe, Profound. Configuration: High Frequency - Precipitously Sloping, Other. Other: Low tolerance To Loudness.
    Device Description
    BETTER HEARING, INC. model L-1 Hearing Aid. Type: Behind-The-Ear (BTE). Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300. Manufactured from materials commonly used in the industry. Hearing Aid has been tested per ANSI S3.22 1987. Fits: Mild to moderate hearing losses. Power: Size 675 Battery.
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    Ask a specific question about this device

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