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The Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® ("Monarch Gen 2") is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

The Monarch Gen 2 eTNS System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are: - . The Monarch® Gen 2 external pulse generator, which controls the electrical stimulation, and - The Monarch® NS-2 external (cutaneous) electrical patches, which are single-use disposable patches worn on the forehead (Figure 3).