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News From the Food and Drug Administration
June 4, 2019

Trigeminal Nerve Stimulator for ADHD

JAMA. 2019;321(21):2066. doi:10.1001/jama.2019.6992

The first medical device to treat attention-deficit/hyperactivity disorder (ADHD) has received FDA marketing authorization. The device is indicated for children aged 7 to 12 years who aren’t already taking prescription medication for ADHD.

Available by prescription only, the Monarch external Trigeminal Nerve Stimulation (eTNS) System is intended for home use during sleep under a caregiver’s supervision. The cell phone–sized device is connected with a wire to a small patch that adheres to a patient’s forehead. It generates a low-level electrical pulse that should feel like a tingling sensation on the skin.