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510(k) Data Aggregation

    K Number
    K130790
    Device Name
    LYRIC2
    Manufacturer
    PHONAK LLC
    Date Cleared
    2013-06-27

    (97 days)

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

    PHONAK LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lyric 2 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
    Lyric2 is a disposable, programmable, deep-canal, extended-wear, air conduction hearing device, It uses an analog, digitally programmable WDRC ("Wide Dynamic Range Compression") circuit with very low power consumption. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The amplification characteristics are contained in digitally programmable memory, and adjustment of device parameters is achieved through the proprietary Fitting System and Software. The Lyric2 consists of: - A programmable application specific integrated circuit ("ASIC") for analog signal processing. . An analog microphone receives sound waves that will be amplified and transmitted to the speaker. - A custom made built-in battery to power the amplification circuit. . - A magnetic sensor to program device parameters and to remotely control user settings (On/Off/Sleep/Volume). - Mechanical components to protect the device from cerumen. . - A removal loop to allow the user and/or professional to remove the device. . - . Seals that allow the device to fit comfortably in the ear canal Accessories available for Lyric2: - User Remote Control - . Device sizer to determine best device size - Length sizer to determine insertion depth . - . An insertion tool for insertion and removal of device and device sizers - A dedicated software and programming interface to program the device with customer · ● specific settings
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    K Number
    K123450
    Device Name
    PHONAK TINNITUS BALANCE
    Manufacturer
    PHONAK LLC
    Date Cleared
    2013-02-11

    (94 days)

    Product Code
    KLW
    Regulation Number
    874.3400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHONAK LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The target group for the Phonak Tinnitus Balance software feature are adults 18 years of age or older with tinnitus who also desire amplification. The Tinnitus Balance software feature and accompanying hearing aid amplification is fit by a licensed hearing healthcare professional (audiologist, hearing aid specialist, notolaryngologist) familiar with the diagnosis and management of tinnitus. Phonak hearing aids provide amplification to address sensorineural, conductive, or mixed hearing losses. Depending on the specific model, Phonak hearing aids cover fitting ranges from mild to profound hearing losses. Before being fit with Tinnitus Balance, individuals presenting with tinnitus should be assessed by a licensed ear physician to confirm the source of their tinnitus is not due to any of the following medical conditions: • Visible congenital or traumatic deformity of the ear · Any active drainage from the ear within the previous 90 days · Sudden hearing loss within the previous 90 days · Acute or chronic dizziness • Unilateral hearing loss of sudden or recent onset within the previous 90 days • Pain or discomfort in the ear
    Device Description
    The Tinnitus Balance software feature is a broadband noise generator embedded in the firmware of selected Phonak hearing aids. It provides a means of sound enrichment that can be used as part of a tinnitus management program to provide relief from tinnitus. By combining a broadband noise generator and hearing aid, the patient is able to wear a single device throughout the day for both tinnitus relief and amplification. The Tinnitus Balance software is enabled and fit by a licensed hearing healthcare professional together with the hearing aid's amplification to meet the individual needs of the patient.
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