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510(k) Data Aggregation

    K Number
    K091682
    Device Name
    LSVT C OR LSVT COMPANION, MODEL V.1
    Manufacturer
    Date Cleared
    2009-08-20

    (71 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LEZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LSVT Companion Device is designed: To be used as a technical aid complementing person speech therapy to improve the vocal loudness of persons with Parkinson's disease. To be used with adults, 18 years of age or older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes. To be used for voice/speech impaired adults, 18 years of age and older, who are able to follow the directions of a Speech-Language pathologist. This device is sold only to licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol. This certifies them to provide LSVT for patients with Parkinson's disease and other communicative impairments. The following specific labeling, therefore, is provided on the product: Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner. The LSVT Companion is designed as a technical aid for this behavioral intervention to increase communicative effectiveness. A "home study" function allows patients to complete voice exercises either under direct supervision by the practitioner in the clinic environment or at home, with feedback of performance provided to the clinician by results reporting via e-mail.
    Device Description
    The sound produced by an individual's voice is received by a calibrated microphone and converted to a visual display which consists of different visual and auditory feedback. The individual is given a target range of both vocal intensity (loudness) and fundamental frequency (pitch) and instructed to maintain a given loudness and or pitch for a given duration. Increases in the complexity of the spoken material are combined with these targeted vocal parameters. In this way, individuals are trained to increase both vocal loudness and variations in pitch through a series of exercises. This approach is designed for speech and hearing impaired adults, over the age of 18, who are unable to speak at a consistent and audible level of loudness such as those with Parkinson's disease and other causes. The device consists of software that allows clinicians to manage speech therapy for clients as well as allow clients to perform speech "homework" on their home PC The Graphical User Interface (GUI) contains two modes of operation - client and clinician. In each mode, the speech therapy tasks are presented to the user and feedback is continually being given. The device collects data on the variables trained (vocal sound pressure level, fundamental frequency, and duration of phonation) and directs individuals through a series of speech exercises, while providing online feedback. These data are recorded to a file that can be downloaded and analyzed by the clinician. Targets for vocal loudness, F0 and duration can be individualized and revised as often as needed. The interface was developed to be simple to use, while carefully considering the specific visual, motor, cognitive and voice/speech needs of individuals with Parkinson's disease and other communicative impairments. The backgrounds were designed in bright contrasting colors which have common meaning (e.g., green means "go") to make the targeted goals easier to identify. In addition, the visual displays utilize concrete, familiar objects (e.g., thermometer, piano, clock) which are designed to be intuitive and require little interpretation. Due to the fact that the device is intended to be used without a face to face clinician, feedback emulates what would be received from a clinician in a therapy session. Thus, in addition to the written comments shown on the screen, a wide variety of auditory feedback phrases, such as "Good job!", "Let's get louder," "Great!", "Can you go any higher?", and short instructions at the beginning of each exercise have been incorporated. The Sound Server works with the GUI in that it sends it data from the microphone at regular intervals so that graphs can be created, feedback can be given to the user, and results for the speech tasks can be written.
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    K Number
    K982396
    Device Name
    VISIVOX, MODEL V-2
    Manufacturer
    Date Cleared
    1998-09-14

    (67 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LEZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used as an assistive device and training aid, complementing personto- person speech therapy: 1.For the deaf, and for people with hearing impairments who do not perceive the loudness of their speech. 2. For people with speech impairments who are unable to speak at a consistent and audible level of loudness. The impairments may be due to stroke,Parkinsons', traumatic head or spine injuries, cleft palate, laryngectomies or other causes. 3. For speech- and/or hearing impaired people of any age who are able to follow the directions of a speech therapist or audiologist.
    Device Description
    The sound volume produced by an individual's voice is received by a microphone and converted into a visual display which consists of a series of multicolored light-emitting diodes arrayed on a light-bar. The number and color of the lights which are sequentially actuated represent changes in the sound volume. Each of the sixteen lights represents a logarithmic 3dB per step variation in the volume of the acoustic signals. The device consists of a metal box, dimensioned 11.75"x 8.25" x 2.75" which weighs 9.5 lb. A hinged lid allows access to the interior. A 12V lead-acid battery and the electronics required for operation of the device are affixed to the interior of the box. A transformer/recharger, a first cable having an external microphone at one end, and a second cable having a light-bar comprising a plurality of light-emitting diodes at one end, are stored, unanchored, inside the box. The front panel of the box includes an off/on switch, a volume adjustment knob, a battery recharger connector, a light-bar connector, an internal microphone, an external microphone connector, and a battery status indicator light. Power is supplied by the 12V battery and/or, via the battery recharger, by 120V AC current. To operate the device, the free end of the cable having the light bar at its other end, is plugged into the designated connector at the outside of the box; the speaker is positioned so as to face the built-in microphone, and the light bar is placed within his or her line of vision. The volume is adjusted so that no light signals are displayed. Upon receiving acoustic signals from a speaker one or more lights will appear- and disappear - depending on the sound volume produced by a speaker. If it is inconvenient for a speaker to face the built-in microphone, (for instance, if he or she is bedridden or in a wheelchair) the cable with the external microphone at its free end may be plugged in. The external microphone may then be handheld or deposited in a clasp provided on the light bar, so that it faces the speaker. Substitution of the external microphone shuts off the built in microphone to prevent interference.
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