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5/5/2008
David Speidel, M.S., FAAA, Director of Audiology Services, Interacoustics USA
I was informed that the FDA has told manufacturers not to sell equipment already set up to conduct VEMP testing or to promote the VEMP (by offering software to make it easy to conduct this test). I was also told that I should not be doing a test like the VEMP if the FDA is not recommending it. Is this information correct? Is it ok to do VEMPS on patients?
Correction/Modification to 4/14/08 posting by David Speidel
After further discussions with a variety of professionals on this topic I felt that I needed to clarify my original response – which may have been misleading or misunderstood. It is important that the health professional involved in various diagnostic assessments understand the difference between their responsibilities and those of the manufacturer of diagnostic equipment.
As it relates to the manufacturers – for the time being - VEMP is a software application that has not been cleared by the FDA. All manufacturers of VEMP need a cleared 510(k) in order to market the VEMP test and the FDA has requested that the distribution, marketing, sales and use of VEMP discontinue until a 510(k) has been cleared for this software application.
Audiologists may find this confusing and come to the conclusion that they must cease the clinical application of the VEMP test. However, the AAA position statement actually includes the VEMP test as part of its recommended battery of tests and as part of an Audiologists ‘scope of practice’ when evaluating patients for balance disorders.
In conclusion, for the time being, when an Audiologist configures a device to perform a VEMP test he/she is ultimately liable for this decision. This decision should obviously be based upon ones education, training and proficiency level. Again, keep in mind that manufacturers that have removed VEMP from the market (temporarily), until their 510(k) is cleared, would not be held responsible for the audiologist who configures the device to perform VEMP.
David Speidel holds a Masters Degree in Audiology from the University of Wisconsin – Oshkosh (1979). He has been in the field of Audiology for over 25 years, first in clinical practice and then 15 years as a sales and support representative for an equipment distribution company. Since 1997 David has been working in a sales and audiology support capacity in the William Demant Group (Maico for 3 years and then Interacoustics until the present).
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