GN Otometrics recently received FDA approval of their EP Charter VEMP device. FDA approval for VEMPs has been a topic of discussion in the Audiology/ENT world over the past several years. While evoked potential systems have had the capability of performing VEMPs, manufacturers have been prohibited from marketing this feature. As recently as January, 2015, ENT Today reports VEMP’s are not FDA approved
Over that several year period, VEMPs have been used as a sensitive indicator of Superior Canal Dehiscence. The literature supports the expanded use of this test. I have pasted relevant excerpts from GN Otometrics application and the subsequent FDA response. To view the application and response in full, click here.
GN Otometrics Application (excerpts)
“The ICS Chartr EP 200 system measures evoked potentials from the patient using repeated auditory stimuli and averaging EEG or EMG activity in order to abstract the response from the noise resulting in an analysis of the auditory/vestibular system functions.”
“One added item as compared to the standard EP200 is the VEMP monitor. The Chartr EP (USB) VEMP monitor assesses the level of tonic EMG and displays if the level is adequate or inadequate. The monitor light will display the following based on the EMG level: Low (blue) -EMG level is below the Min value- Good (green) – EMG level is between Min value and the Max value – High (amber) – EMG level is above the Max value
Summary: VEMP is an evoked potential (EP) just like ABR obtained using any commercially available EP system. The unique feature with the ICS Chartr EP 200 is the ability to perform EMG monitoring during VEMP data collection.”
FDA Response (excerpt)
“We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.”
Comments:
In the application, GN Otometrics describes filter settings for VEMP, but not for other evoked potential testing performed with the EP Charter. They do not mention electrode recording site. It appears the FDA approved this application on the basis that VEMP tests are not substantially different from other approved evoked potential tests. It does not appear that the unique aspect of the GN Otometrics system (the EMG monitor) was a deciding factor in the approval. Others may read this differently, but my interpretation is that VEMP protocols are now FDA approved.
Photo courtesy of www.canadianaudiologist.ca
