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510(k) Data Aggregation
K Number
K982396Device Name
VISIVOX, MODEL V-2
Manufacturer
Date Cleared
1998-09-14
(67 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
RSQ, LLC.
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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