GN Otometrics, a hearing and balance screening and assessment solutions company, announced the release of its 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 reportedly the first EP system in the United States with FDA-cleared VEMP testing protocols.
According to Otometrics, 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. The company says that, up until now, the FDA has not recognized the VEMP testing protocols as an approved procedure in the US.
“We are proud to be the first manufacturer who can deliver an EP system with FDA-cleared VEMP testing protocols,” said 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 a 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.”
Otometrics notes that 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 company reports that the ICS Chartr EP200 with VEMP offers a third channel for EMG monitoring throughout the entire test, not only a 20-second pre-stimulus window. A specially designed differential electrode, pre-programmed 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,” said 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.” Craig noted that 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, which is the exclusive distributor of these products in the US, offers more information about the ICS Chartr EP 200 and the complete Otometrics balance assessment portfolio, on its website.
Source: GN Otometrics