Last week, I posted a short blurb about the FDA approval of the application by GN Otometrics for their EP Charter system with VEMP capability and EMG monitoring. A few days later, Jill Craig, audiologist and product manager at Otometrics, contacted me with additional information and a slightly different perspective on the FDA approval. Here is what Jill had to add:
“I’d like to offer another interpretation based on my experience working with the FDA on this project and others. The FDA clears devices and not test protocols An example of this is to think about audiometers. The FDA clears an audiometer–not audiometry or the Hughson-Westlake method. Or, to relate this to evoked potential (EP) testing, consider electrocochleography (EcochG). EP systems are cleared to perform the test. The EcochG test protocol itself is not approved. The ICS Chartr EP200 with VEMP was cleared based on several years of information and data provided by the company. The clearance includes the specific method that Otometrics uses for EMG monitoring.
When VEMP was taken off the market several years ago, manufacturers tried to explain “it’s just another protocol”, the FDA disagreed. The ICS CHARTR EP200 with VEMP has been deemed a safe and reliable device, according to the FDA. They did not investigate the parameters but the reliable results the device provided on normal and abnormal patient populations. Using patient data and research publications, Otometrics was able to provide evidence that the ICS CHARTR EP200 with VEMP was reliable and safe. It is important to note that systems capable of performing a VEMP do not all work the same way. My interpretation is that if they do not perform the same way, we cannot use a blanket clearance for all.
I appreciate the opportunity to offer another perspective.
Photo courtesy of www.canadianaudiologist.ca