On July 15, FDA announced its approval of the first brain- function-based medical device to help diagnose attention deficit hyperactivity disorder (“ADHD”) in children and adolescents. The approved device, the Neuropsychiatric Electroencephalogram-Based Assessment Aid (“NEBA”) System, uses an electroencephalogram (“EEG”) to measure brain waves with sensors attached to a child’s head, which are wired to a computer. After fifteen to twenty minutes of information-gathering, it provides a read-out of the types and timing of electrical impulses, i.e., waves, emitted by brain nerve cells. Because two kinds of brain waives–theta and beta–may be more common in ADHD children, physicians can use this information to confirm an ADHD diagnosis or direct further diagnostic testing.
EEG technology has been around since the early 1900s and is often used to diagnose sleep disorders, measure unconsciousness, evaluate the brain post-head trauma, and monitor the brain during surgery. ADHD, which results in attention difficulties, hyperactivity, impulsivity and behavioral problems, is one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, nine percent of U.S. adolescents have ADHD and the average age of diagnosis is seven years. “Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam,” explained Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health (“CDRH”)
The manufacturer of the NEBA System, NEBA Health of Augusta, Georgia, provided FDA with data including a clinical study that evaluated 275 children and adolescents (ages 6 to 17 years) with attention/behavioral issues, using both the approved device and standard diagnostic testing such as questionnaires and physical exams. An independent group of ADHD experts also reviewed the data and reached a consensus as to whether each subject had ADHD. According to FDA, the side-by-side results “showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone.”