Indications for Use:
The balanceback™ Mobile iVNG device is intended for recording, viewing, and analyzing
eye movements in support of identifying balance disorders in human subjects. The Mobile
iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor’s
office or health care facility. This device provides no diagnoses nor does it provide
diagnostic recommendations.
Description of the iVNG Device and Summary of the Technological Characteristics:
Eye movements have long been known to provide important clues to the identification and
location of balance disorders. Physicians and other clinicians employ the VNG system toconduct a set of established, well-known and well-documented eye movement tests. The
results of the VNG eye movement tests are combined with other clinical information so that
the attending clinicians may render findings on the health of the patient’s primary balance
sensors and related balance processing system.
Using the Mobile VNG, clinicians guide patients through a series of eye movement tests. A
testing battery (i.e., an examination) typically consists of all eight tests supported bythe
VNG: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, and highfrequency
head shake. The attending physician may select one, several, or all tests, and has
full flexibility in determining the sequence of the tests to be performed.
The patient under examination wears the iVNG goggles. The goggles contain one IR light
source and one JR camera for each eye. The JR video cameras sense the infrared signal
reflected from the eyes and create a continuous monochromatic (grayscale) video motion
picture stream of the eyes. The infrared signal is used because the human eye cannot detect
the presence of the infrared signal and therefore this illumination does not create
perturbations in measurements of eye movement. Measurements may therefore be made
both in the presence and in the absence of visible light, thus providing clinicians with
maximum flexibility for making measurements in a wide variety of situations.
The video stream from the IR cameras is digitized and transferred into the memory of the
digital computer where signal processing software tracks, records, analyzes and displays eye
movements for the attending clinician. The Mobile iVNG system makes appropriate
calculations and presents reports of well-known and well-documented parameters associated
with each eye movement test.
Some eye tests require the patient to follow a visual stimulus. A projector, controlled by the
iVNG hardware, displays stimuli on any light-colored surface, such as a wall or projection
screen. The goggles and Mobile iVNG software record the patient’s eye movements while
he/she follows the stimulus.
Substantial Equivalence:
The balanceback Mobile iVNG device is substantially equivalent to the balanceback
iVNG Workstation System (Desktop Configuration). This device supports the recording,
viewing, and analyzing of horizontal and vertical eye movements to assist in the
identification of balance disorders in human subjects. This device uses near identical
technology, including the same goggles mounted with video cameras and software handling
all the same tests (such as: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, and
optokinetic examinations). These devices use the same sampling rate and similar
illumination wavelengths. The primary differences are the configuration (from desktop to
laptop) and the controls of the control box (additional video management hardware).
Balance Test System Comparison for your review.
Balance and fall prevention therapies are billable under CPT codes. Doctors can also bill cash for balance and fall prevention treatment and therapies as well.