Neurovalens announced Oct. 31 it has received FDA 510(k) clearance for its Modius Sleep device intended to treat chronic insomnia. By delivering a small and safe electrical pulse to the head for 30 minutes before bed, Modius Sleep is designed to improve insomnia.

About Modius Sleep

According to Neurovalens, Modius Sleep treats the underlying issues leading to chronic insomnia without the need for surgically implanted electrodes. The device stimulates the vestibular nerve to indirectly influence the hypothalamus and positively impact the body’s circadian rhythm. By stimulating neurons in the brain, Modius Sleep reduces time to fall asleep and nighttime awakenings.

While the headset is in use, individuals can continue to do other activities, such as watching television or reading. With FDA 510(k) approval, the non-invasive device can be sold directly to people with chronic insomnia in the U.S. who have a doctor’s prescription.

About chronic insomnia

Chronic insomnia is a sleep disorder characterized by persistent difficulties in falling or staying asleep, resulting in disrupted sleep patterns and daytime symptoms. It significantly impacts various aspects of life, affecting work performance, decision-making, relationships, mood and overall quality of life. Approximately 10% of individuals experience chronic insomnia, defined by sleep disturbances occurring at least three times a week and lasting for a minimum of three months.

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