At a company office in downtown Augusta, NEBA Health President Howard Merry was clearly happy as he read over the FDA news release.
“It’s been seven years of our lives” working to get the device approved, he said.
Called the Neuropsychiatric EEG-Based Assessment Aid System or NEBA System, it uses electroencephalogram readings of the beta and theta brain wave frequencies and compares them to clinically validated ranges of those readings associated with ADHD. The device would be used to confirm a diagnosis of ADHD in a child or adolescent ages 6 to 17 who has symptoms of ADHD who has gone through other testing, or it might point the clinician to other testing to confirm ADHD or to testing for other conditions.
“Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam,” Christy Foreman, the director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a statement. “The NEBA System along with other clinical information may help health care providers more accurately determine if ADHD is the cause of a behavioral problem.”
ADHD is one of the most common mental disorders affecting children, and affects an estimated 9 percent of adolescents and 4.1 percent of adults in the U.S., according to the American Psychiatric Association.
The most common symptoms – difficulty in paying attention, focusing or difficulty controlling behavior – are somewhat subjective and shared with many other common disorders, according to the National Institute of Mental Health.
The Augusta-based company conducted four large clinical trials to help validate its test. The FDA cited one of 275 children and adolescents where the NEBA system and standard diagnostic protocols was evaluated by an independent group of ADHD experts and found to result in a more accurate diagnosis compared to just clinical assessment.