US Approves First At-Home Brain Stimulation Device for Depression

United States Approves First At-Home Device for Treating Depression

The United States Food and Drug Administration (FDA) has approved the country’s first at-home medical device for treating depression , marking a significant shift in mental health care delivery. Developed by Flow Neuroscience , the prescription headset—named FL-100 —allows adults with moderate to severe depression to receive treatment outside traditional clinical settings. The device is expected to enter the US market by mid-2026 .

FDA Clearance and Device Design

The FL-100 headset is intended for supervised home use and offers a non-pharmaceutical alternative to antidepressant drugs, which often cause long-term side effects. The approval came after the FDA applied stricter regulatory standards for brain stimulation devices, introduced in 2019 , reflecting heightened safety scrutiny in this field.

Mechanism of Treatment

The device operates using transcranial direct current stimulation (tDCS) , a technique that delivers a low-intensity electrical current through electrodes placed on the forehead. The stimulation targets the dorsolateral prefrontal cortex , a brain region involved in mood regulation and stress control. Treatment typically follows a 12-week protocol , beginning with frequent sessions that gradually taper. Each session lasts around 30 minutes and is conducted at home under medical supervision.

Clinical Evidence and Safety

FDA clearance was supported by clinical trials involving 174 adult patients . The studies demonstrated a meaningful reduction in depressive symptoms compared to control groups, with over half of participants achieving remission . Reported side effects were generally mild and temporary, including headaches and minor skin irritation. Regulators concluded that the device’s benefits outweigh its risks, even if improvements are described as modest.

Cost and Broader Impact

Flow Neuroscience estimates the device will cost $500–$800 , with no recurring subscription fees. Insurance coverage discussions are underway. Given that depression affects more than 20 million adults in the US , experts believe such home-based therapies could significantly expand access to care and reduce reliance on medication.

Exam Oriented Facts

• FL-100 uses transcranial direct current stimulation (tDCS) .

• Approved for adults aged 18 and above .

• FDA tightened brain stimulation device regulations in 2019 .

• Trial findings published in Nature Medicine (2024) .