The agency said Monday it cleared the NEBA system to help confirm ADHD for people ages 6 to 17. Doctors can use the device to confirm an ADHD diagnosis or to determine if more testing is necessary.
The device, from Augusta, Ga.-based NEBA Health, measures the frequency of two standard brain waves known as theta and beta waves. Children with ADHD tend to have a higher ratio of these waves than children who don't have the disorder.
The FDA approved the 15- to 20-minute test based on a study of 275 patients who had attention or behavioral issues. Clinicians evaluated the patients using the NEBA Health System as well as standard diagnostic tools like behavioral questionnaires, IQ tests and physical exams. An independent group of researchers then reviewed the data and reached a consensus on whether each patient had ADHD or not. The study results showed that use of the NEBA System helped doctors make a more accurate diagnosis than using traditional methods alone.
"Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," said Christy Foreman, director of FDA's Office of Device Evaluation, 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."
Estimates of ADHD in U.S. children vary, but the American Psychiatric Association states that it affects 3 to 7 percent of school-aged children.