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Why is FDA Clearance of VEMP Testing Important to Balance Care Today?

Ian S. Curthoys, PhD, Faith Akin, PhD, Jill Craig

February 8, 2016

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Question

What is the significance of the FDA clearance of VEMP positional and oculomotor testing to balance care today?

Answer

Ian Curthoys: Adding these tests to your vestibular test battery is the key. Combining Vestibular Evoked Myogenic Potential (VEMP) and head impulse testing is an outstanding way to assess the entire peripheral vestibular system. It’s faster and offers more precise diagnosis in many cases. It’s rewarding to see all of these tools become available to clinics and used to provide physicians with the answers they have been searching for.

Jill Craig: At Otometrics, we are committed to faster patient diagnosis. We work in close collaboration with our industry partners to improve the lives of patients suffering from balance disorders. There are existing EP systems today that run a VEMP test - based on parameter settings; however, the ICS Chartr EP 200 by Otometrics is the only device that is FDA-cleared for VEMP testing as of today. That said, it is the only equipment that the FDA has deemed safe and reliable to perform the VEMP test.

Our recent FDA clearance is a significant step forward for clinicians treating patients with balance disorders, and gives audiologists and physicians more options when assessing patients with a vestibular disorder. Balance care professionals can now test the entire peripheral vestibular system as individual pieces. We can now identify specifically if the breakdown is a problem within the peripheral vestibular system, where the dysfunction may lie or if the issue lies within another system. This level of accuracy contributes to better patient care and a faster diagnosis.

Supplementing our pursuit of vestibular testing excellence, I am excited to share that in addition to ICS Chartr EP 200 with VEMP – which is discussed in detail in a previous interview.  Positional and ocular testing with our modular ICS Impulse® solution are now also FDA-cleared. With these new breakthroughs, clinicians in the U.S. can perform a complete test of the vestibular peripheral system in the most efficient and accurate way. Now with the addition of VEMP and vHIT, you can efficiently test the entire peripheral vestibular system as individual pieces, allowing you to identify the site of the dysfunction. This new level of accuracy contributes to a faster and more precise diagnosis and allows you to provide better patient care and a faster diagnosis.

Faith Akin: To Jill’s point in regards to VEMP testing, FDA clearance opens doors for widespread clinical use of the VEMP in the United States. There have been approximately 800 peer-reviewed articles published on cVEMP in the past 20 years. In a recent survey, however, we found that most vestibular audiologists in the U.S. do not routinely use cVEMP as a clinical test of vestibular function4. One obstacle to widespread clinical use in the U.S. may be that reimbursement for VEMP as a clinical procedure has been impacted by the lack of FDA clearance. The FDA clearance clears the way for the American Speech-Language-Hearing Association (ASHA) and the American Academy of Audiology (AAA) to begin the process towards getting a VEMP CPT code.

Jill: We have more educational material available at www.audiologysystems.com/vemp.  Thank you for your question.

Visit www.audiologysystems.com or the Otometrics / Audiology Systems Expo Page on AudiologyOnline for more information.


ian s curthoys

Ian S. Curthoys, PhD

Dr. Ian S. Curthoys is Emeritus Professor of Vestibular Function, University of Sydney, and School of Psychology Honorary Consultant, Neurology Department, Royal Prince Alfred Hospital.  He has been engaged in vestibular research in the laboratory and the clinic since 1968. In that time he has published some 200 papers in estemeed international journals on all aspects of vestibular function, eye movement disorders, and clinical tests of canal and otolith function. In 1988 Halmagyi and Curthoys published the article “A clinical sign of paresis” (Arch Neurol 1988;45:737-739 ) introducing the Head Impulse Test.

 


faith akin

Faith Akin, PhD

director of the vestibular laboratory at James H. Quillen VA Medical Cente

Faith W. Akin, Ph.D. is the director of the vestibular laboratory at James H. Quillen VA Medical Center and an associate professor in the Department of Audiology and Speech-Language Pathology at East Tennessee State University. Her research interests are in the area of vestibular assessment.


Jill Craig

Jill Craig has a Masters degree in Audiology. Jill worked for five years in dispensing and neuro-otology offices then moved in to audiology equipment sales and training. This led to both regional management and consulting positions. In 2009, Jill left distribution and shifted to manufacturing and R&D. Jill currently is a global product manager with Otometrics leading the EP and OAE product lines.


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