Robert E. McCarthy, Ph.D., McCarthy Counseling Associates, PA and The Center for Psychophysiological Assessment and Treatment - Comment

August 22, 2011 Nancy K. Stade, Deputy Director for Policy Center for Devices and Radiological Health Food and Drug Administration 5630 Fisher Lane, Room 1061 Rockville, Maryland 20852 Re: The Federal Register, Vol. 76, No. 152, pgs. 48062-48070. Proposed Rule: “Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator.” [Docket No. FDA-2011-N-0504]. Dear Ms. Stade: I am submitting this response at the request of the Food and Drug Administration (FDA) in its Proposed Rule for Cranial Electrotherapy Stimulation (CES) issued in the Federal Register on August 8, 2011 (76 F.R. 152, p. 48062). As a licensed mental health practitioner who has utilized CES in my practice for more than twenty-five years, I wanted to share with the FDA my own clinical findings on the efficacy and safety of CES. I own a group behavioral medicine practice in Myrtle Beach, South Carolina consisting of five full-time licensed mental health clinicians, and three full-time administrative staff. It is presently the only program in the entire country fully accredited by the American Association of Integrative Medicine (AAIM) for providing quality integrative healthcare. For over twenty-five years, CES has been an integral part of our treatment programs for anxiety, depression, chronic pain, and insomnia. In addition, and because it tends to increase global alpha activity in the brain, CES is rapidly becoming a cornerstone of our successful recovery work with addicts. During these twenty years, not only has CES been one of the most efficacious treatment modalities used in our practice, but there have been relatively few adverse side effects. The only complaints I have personally ever heard patients verbalize involve dizziness or nauseousness. These symptoms can usually be eliminated by reducing the intensity of the CES signal. For chronic pain patients, being able to routinely treat them systematically as well as regionally on a daily basis