FDA Approves Home Brain-Stimulation Device for Depression Treatment

The U.S. Food and Drug Administration has cleared a home brain-stimulation device designed to help treat depression. The prescription headset, developed by Sweden-based Flow Neuroscience, delivers low-level electrical stimulation to areas of the brain linked to mood and stress control.

This device represents a significant step in expanding access to depression treatment, particularly for individuals who may not have the means to pursue in-office procedures like transcranial magnetic stimulation.

Flow CEO Erin Lee emphasized their goal of democratizing access to mental health care, indicating that the device could be used in any home across the United States. The headset is projected to be available in the U.S. by mid-2026 at a cost of approximately $500, and the company is in discussions with insurers to facilitate coverage.

The device employs transcranial direct current stimulation, a method that has been subject to various studies with inconsistent results. A key clinical trial involving 174 participants demonstrated that patients using the device experienced greater relief from depression symptoms compared to those using a placebo, with about 58% reaching remission.

Reported side effects were minor, including mild skin redness and itching, with no serious safety concerns noted. The FDA acknowledged the research limitations but concluded that the benefits outweighed potential risks.

The device is intended for adults 18 and older who do not have treatment-resistant depression and is rechargeable, lasting around three years while pairing with a smartphone app for treatment sessions.

Flow has already sold 55,000 devices in Europe since 2019 and has recently expanded into Australia. This FDA approval marks a new era of treatment for depression, according to Dr. Daniel Blumberger of the Center for Addiction and Mental Health in Canada, who remarked that the data supporting this device is stronger than that of other home stimulation devices.