You probably remember that I am in the process of creating some special headphones for surgery. The patent is almost finalized but recently, I hit a little bump in the road. Seemingly out of the blue, it was brought to my attention that I would need FDA approval. At first I though “that can’t be right” but the more I have investigated it, the more I have found that it does seem to be true! It seems that if you’re making any sort of medical claim about a device, you must have FDA approval, whether it’s an invasive device or not. Interesting, eh?
Headphones for Surgery
About the Author: DrAlice
Dr. Alice Cash is one of the world’s few clinical musicologists. Based in Louisville, Kentucky, USA, she brings to her work over 40 years of professional experience as a college professor, clinical therapist, solo and chamber music performer and composer. Since 1990, Dr. Cash has been in the field of Music Medicine and conducted clinical research at the University of Louisville School of Medicine, under the guidance of Dr. Joel Elkes, Dr. Leah Dickstein, and Dr. Rif El-Mallakh. Her clinical work at the University of Louisville lead to her career in music medicine. In addition to her work with the University of Louisville, Dr. Cash lead the development of using music a hospital setting at Baptist East Hospital, Louisvile, KY. She has founded 3 companies: Healing Music Enterprises, Surgical Serenity Solutions and Crescent Hill Counseling.