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Revolutionary ICS Impulse Cleared by FDA

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GN Otometrics Introduces the Gold Standard in Head Impulse Testing.

Schaumburg, IL. - February 19, 2013 – GN Otometrics, the world leader in hearing and balance diagnostic systems, announced today that ICS Impulse, the first and only video head impulse testing system (vHIT), has been cleared by the Food and Drug Administration for sale in the United States.   Among many other capabilities, ICS Impulse can assess and document the vestibular function in both ears in less than ten minutes, from patient entry to reporting - an industry first.  ICS Impulse is the result of almost 20 years of research, conducted in conjunction with head impulse testing thought-leaders Michael Halmagyi, M.D., and Ian Curthoys, Ph.D.  It is the only such test to meet the standards of Halmagyi and Curthoys, who are credited with having described the head impulse test in 1988.  ICS Impulse is the new gold standard in head impulse testing.

ICS Impulse“ICS Impulse is revolutionizing vestibular testing and taking it to a whole new level,” said Dan McNulty, general manager of GN Otometrics.  “It is the culmination of almost two decades of research -- a true collaboration between academia and industry -- and it has resulted in the development of an innovative assessment device that has finally realized the potential in head impulse testing.  It’s a major step forward for the industry and Otometrics is extremely proud to have been the driver in bringing this exceptional new device to market.”

Vestibulo-ocular Reflex Assessment Based on Real-life Stimuli, Plus Testing of All Six Canals

ICS Impulse generates objective measurement of both head and eye movement using a fast and precise system to assess the vestibulo-ocular reflex.  The high-frequency stimuli used in vHIT is similar to that used in daily life, as when crossing a street, sitting in a restaurant or turning quickly toward a sound.  ICS Impulse also features LARP/RALP functionality, which tests the anterior and posterior canals, enabling the assessment of all six semicircular canals, in a clinical setting -- another industry first.

Unprecedented Testing Speed and Lightweight Goggles Enhance Patient Comfort

ICS Impulse revolutionizes the testing process, reducing overall testing time and enhancing patient comfort.  A dramatically shorter testing time of 10 minutes, from patient entry to reporting, is rapidly establishing ICS Impulse as the first-line test conducted in vestibular assessment.    Additionally, patient comfort is significantly improved by the ICS Impulse goggles, which are the lightest in the industry.  They allow for smaller amplitude head impulses of only 15 to 20 degrees, which result in a more pleasant testing experience for the patient.  Additionally, ICS Impulse enables the testing of children, bed-ridden patients or any patient for whom caloric testing is not an option.

“Our customers are often saying they don’t know how they assessed patients without this vital information,” said Wendy Crumley-Welsh, product manager ICS Impulse at GN Otometrics.  “With ICS Impulse in their test battery, physicians around the world are realizing significant time-savings and have more confidence in their diagnosis of dizzy patients.  Patient-friendliness, diagnostic accuracy of all six semicircular canals and time-efficiency are establishing ICS Impulse as the first test in our customers’ workflow.”

Extensive User Support

Otometrics has launched two dedicated Web sites to provide users with comprehensive support.  At https://www.icsimpulse.com/, users will find extensive information and resources to learn more about ICS Impulse and vHIT.  It features a library of educational materials including training videos, white papers and articles by experts which include instruction on how to conduct head impulse testing.  There is also a blog where ICS Impulse users can communicate with the people behind the product, as well as other balance experts.

At https://www.headimpulse.com/, ICS Impulse users can explore both the science and practical application of head impulse testing.  The online research library features research material, including videos of Dr. Halmagyi’s classroom lectures and examples of vHIT test results. 

ICS Impulse will be featured in the Otometrics booth at several upcoming trade shows, conferences and meetings including: the Association of Research in Otolaryngology Mid-winter Meeting in February, where Curthoys is presenting; the American Academy of Neurology Annual Meeting, in March, where Halmagyi is presenting; the American Academy of Audiology AudiologyNow Conference in April and the American Academy of Otolaryngology-Head and Neck Surgery Annual Meeting in September.

ICS Impulse is available for immediate delivery.  For more information, customers should contact their exclusive Otometrics distributor.

About GN Otometrics North America

GN Otometrics is the world's leading manufacturer of hearing and balance solutions, ranging from infant-screening applications and audiologic diagnostics, to balance testing and hearing-instrument fitting. A major part of the solutions are integrated through the OTOsuite software to help customers optimize their workflow. The Otometrics product brands MADSEN, AURICAL and ICS are exclusively distributed through Audiology Systems Inc. and dedicated partner distributors in the US. Visit https://www.otometrics.com/ or the Otometrics Expo Page for more information.

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