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510(k) Data Aggregation

    K Number
    K964180
    Device Name
    AUDIO 'D' SOUND SELECTOR POWER (SSP)
    Manufacturer
    HEARING SOLUTIONS, INC.
    Date Cleared
    1996-11-26

    (39 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
    Device Description
    AI/ML Overview
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    K Number
    K962798
    Device Name
    AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
    Manufacturer
    HEARING SOLUTIONS, INC.
    Date Cleared
    1996-09-09

    (53 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
    Device Description
    AI/ML Overview
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    K Number
    K961308
    Device Name
    AUDIO 'D' INTIMA CIC
    Manufacturer
    HEARING SOLUTIONS, INC.
    Date Cleared
    1996-05-07

    (33 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
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K960935
    Device Name
    AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)
    Manufacturer
    HEARING SOLUTIONS, INC.
    Date Cleared
    1996-04-03

    (26 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
    Device Description
    AI/ML Overview
    Ask a Question

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