Clinicians can now assess the entire peripheral vestibular system with the Otometrics balance solution portfolio.
Schaumburg, IL - November 2015 – GN OTOMETRICS, a global leader in hearing and balance screening and assessment solutions, announces the release of the Cervical VEMP (cVEMP) and Ocular VEMP (oVEMP) protocols for the ICS Chartr® EP200, as cleared by the US Food and Drug Administration (FDA). The ICS Chartr EP200 from Otometrics is the first EP system in the United States with FDA-cleared VEMP testing protocols.
The vestibular evoked myogenic potential (VEMP) is an assessment technique used to determine the function of the otolithic organs (utricle and saccule) of the peripheral vestibular system. It complements the information provided by the head impulse test (HIT) and other forms of inner ear (vestibular apparatus) testing. Up until now, the Food and Drug Administration (FDA) has not recognized the VEMP testing protocols as an approved procedure in the United States.
“We are proud to be the first manufacturer who can deliver an EP system with FDA-cleared VEMP testing protocols,” says Jill Craig, audiologist and product manager at Otometrics. “It’s been a long journey – we’ve been working with the FDA for more than 5 years on this project – but the result is well worth the effort. We realized early on that it was incredibly important to support audiologists and physicians by tenaciously pursuing FDA clearance. This demonstrates that Otometrics is the clinician’s manufacturer – we are dedicated to helping our customers succeed in helping their balance patients obtain a timely and accurate diagnosis. What’s more, Otometrics is a corporate sponsor of the Vestibular Disorders Association (VEDA). We truly are committed to supporting faster patient diagnosis.”
The FDA clearance is a significant step forward for clinicians treating patients with balance disorders, and gives audiologists and physicians more options when diagnosing a vestibular disorder.
The ICS Chartr EP200 with VEMP offers a third channel for EMG monitoring throughout the entire test, not only a 20-second prestimulus window. A specially designed differential electrode, preprogrammed VEMP protocols, an EMG monitor for patient use in maintaining proper contraction and the normalized asymmetry ratio, gives clinicians an easy-to-use and patient-focused solution.
“There have been many people – employees and customers – who have been involved in this project,” says Jill Craig. “We are especially grateful for the close relationship we have with our customers and their willingness to assist us in this pursuit. It demonstrates the value of a trusted partnership – working together to improve the lives of patients suffering from balance disorders.”
With the Otometrics ICS Impulse® solution and the ICS Chartr EP200, clinicians now have the possibility to perform a complete test of the vestibular peripheral system in an efficient and accurate way.
Audiology Systems is the exclusive distributor of these products in the United States. To learn about the ICS Chartr EP 200 and the complete Otometrics balance assessment portfolio, visit www.audiologysystems.com/balance.
About Audiology Systems
Audiology Systems is a national partnership of industry professionals, audiologists, local instrument experts and Otometrics. The company provides fast and direct access to advanced equipment from leading manufacturers, such as Intelligent Hearing Systems (IHS) and Otometrics, with MADSEN, AURICAL and ICS. Audiology Systems was founded with a clear vision: to elevate customer care through increased professionalism, consultative dialogue and accessibility to customers. Visit www.audiologysystems.com for more information.
About GN Otometrics North America
GN Otometrics is the world's leading manufacturer of hearing and balance solutions. MADSEN®, ICS®, and AURICAL® brands offer product solutions ranging from infant-screening applications and hearing diagnostics to balance testing and hearing-instrument fitting. The OTOsuite software platform helps hearing healthcare providers optimize workflow by providing a single-user interface for multiple test modalities. The Otometrics product brands are exclusively distributed through Audiology Systems Inc. and dedicated partner distributors in the United States. Visit www.otometrics.com for more information. Learn more on the Otometrics / Audiology Systems Expo Page on AudiologyOnline.
