WASHINGTON (AP) -- The Food and Drug Administration says it has approved a nerve-stimulating headband as the first medical device to prevent migraine headaches.
The Cefaly device is a battery-powered plastic band worn across the forehead that emits an electric current to stimulate nerves associated with migraine pain. The device is designed to be used no more than 20 minutes a day by patients 18 years and older.
A 67-person study reviewed by the FDA showed patients using the device experienced fewer migraines per month than patients using a placebo device. The Cefaly did not completely eliminate migraine headaches or reduce the intensity of migraines that occurred.
About 53 percent of 2,313 patients in a separate study said they were satisfied with the device and willing to purchase it for future use.