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    K Number
    K081136
    Device Name
    LYRIC HEARING AID
    Manufacturer
    INSOUND MEDICAL INC.
    Date Cleared
    2008-05-08

    (17 days)

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

    INSOUND MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lyric Hearing Aid is a disposable, extended-wear, air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.
    Device Description
    The Lyric Hearing Aid amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.
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    K Number
    K021867
    Device Name
    INSOUND XT SERIES HEARING AID
    Manufacturer
    INSOUND MEDICAL INC.
    Date Cleared
    2002-11-19

    (166 days)

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

    INSOUND MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.
    Device Description
    The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.
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