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510(k) Data Aggregation

    K Number
    K972344
    Device Name
    MIRACLE-EAR DIGITAL BTE
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-07-23

    (29 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 Configuration: ✓ 1. High Frequency Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other: ✓ 1. Low tolerance to Loudness
    Device Description
    Behind-the-Ear (BTE) Hearing Aid
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    K Number
    K972345
    Device Name
    DAHLBERG/MIRACLE-EAR
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-07-23

    (29 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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 Configuration: High Frequency Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other ski-sloping Other: Low tolerance to Loudness, Compression Limiting, Loudness Growth Compensation
    Device Description
    CIC, ITE and BTE Hearing Aids
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    K Number
    K972346
    Device Name
    MIRACLE-EAR ITE DIGITAL
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-07-23

    (29 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General Indications: A. 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 Configuration: ✓ 1. High Frequency Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other: ✓ 1. Low tolerance to Loudness B. Specific Indications (Only if appropriate): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data).
    Device Description
    To amplify and transmit sound to the ear.
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    K Number
    K970262
    Device Name
    MULTI-CHANNEL COMPRESSION BTE (SD)
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-03-31

    (67 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    Dahlberg Hearing Aid with multi-channel compression circuit
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    K Number
    K964419
    Device Name
    MIRACLE - EAR (ITE/ITC/CIC)
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-02-04

    (126 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    CIC, ITC and ITE Hearing Aids
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    K Number
    K965049
    Device Name
    DAHLBERG (A-554)
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-01-27

    (40 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    BTE Hearing Aid
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    K Number
    K965057
    Device Name
    AUDIOTONE (A554H)
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-01-27

    (40 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    BTE Hearing Aid
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    K Number
    K965063
    Device Name
    AUDIOTONE (A-552)
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-01-27

    (40 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    BTE Hearing Aid
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    K Number
    K964669
    Device Name
    MIRACLE-EAR OR AUDIOTONE
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1996-12-26

    (35 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    Dahlberg Power BTE
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    K Number
    K964794
    Device Name
    DAHLBERG K-AMP BTE
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1996-12-23

    (24 days)

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

    MIRACLE-EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To amplify and transmit sound to the ear.
    Device Description
    Dahlberg K-AMP BTE
    Ask a Question

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