A New Era in Mental Health Has Arrived: FDA Approves First Non-Invasive At-Home Brain Stimulation Device to Treat Depression
Home Device Complements Our Practice’s Medical-Grade Device and Neurofeedback Sessions
A significant breakthrough has arrived for those suffering from depression. This past December, the U.S. Food and Drug Administration (FDA) officially approved the FL-100 by Flow Neuroscience (pictured in blog), the first at-home brain stimulation device for treating moderate to severe depression.
For a decade we have used the same brain stim technology and seen life-changing benefits for depression. A simplified version is now available for daily use at home. Using our device or the new FDA-approved at-home device complements our Neurofeedback sessions and each patient’s recovery time.
While the at-home device has been approved in Europe and the UK since 2019, we have used a medical-grade “high-definition” form for a decade. For years, there has been scientific evidence supporting its use, and this new FDA approval validates that our advanced neurofeedback work is ahead of the curve.
“At our practice, we have been doing non-invasive brain stimulation for more than a decade because they’re so safe, drug-free and effective. It’s exciting that the FDA is finally approving this at-home device. It validates our long experience in this area,” said Dr. Engwall. “Even though the FDA approved device is somewhat limited, it is expected to be inexpensive and safe to use at home. We are excited to help people get the most out of it.”
Many people benefit from using this technology (offered in the FL-100) to shift their brain state out of depression and pairing it with neurofeedback to help them maintain it. For some the FL-100 won’t work for their brain. For those folks, we can assist in identifying the ideal areas to stimulate based on their unique brain waves.
Our approach is “high-definition transcranial direct current stimulation” (or HD-tDCS) which provides a more precise form of stimulation. Our device, or an at-home one paired with neurofeedback sessions, will help sustain the changes from brain stimulation.
What is the FL-100?
Developed by the Swedish company Flow Neuroscience, the FL-100 is a portable, wireless headset that resembles a pair of high-tech headphones rather than a medical device. It uses tDCS to deliver a gentle, low-intensity electrical current to the brain’s prefrontal cortex. This specific area of the brain targeted by the device—the dorsolateral prefrontal cortex—is often underactive in people with depression.
By stimulating this region, the device helps “rebalance” brain activity and form new neurological pathways, leading to faster improvement in mood regulation and the stress response. The approval of the FL-100 marks a significant shift in mental health care. For the first time, patients can access clinical-grade neuromodulation therapy from their own couch.
Key highlights of the device include:
-Non-Drug Alternative: It offers a way to treat depression without the systemic side effects often associated with medication, such as weight gain or fatigue.
-Accessibility: By moving treatment from the clinic to the home, it removes barriers for people in rural areas or those unable to make it to the doctor’s office.
-Proven Efficacy: In a major clinical trial published in Nature Medicine, 58% of participants achieved full remission after 10 weeks of treatment.
-Rapid Results: Real-world data shows that 77% of users see clinical improvement in as little as three weeks. The app guides users through each session and helps track progress, providing a structured yet flexible approach to recovery.
Looking Ahead
The new at-home device is expected to launch this summer in the United States. It will be available by prescription, ensuring patients use it under a psychiatrist's guidance. Most patients will need a more sophisticated, medical-grade approach, but at-home tDCS expands access to more people.
Read more here.
If you plan to use the at-home device, we recommend that it be considered as part of a treatment plan with a psychiatrist who is trained in tDCS for depression. Dr. Engwall and his team are experts in this area, only a small number of psychiatrists across the country have the experience in treating people with tDCS. Dr. Engwall, is the only one in this area offering this expertise, and is pleased to lend his knowledge to help you or a loved one overcome depression.
Contact us to schedule a consultation.
Dr. Engwall was among a handful of psychiatrists across the United States who took the Non-Invasive Neurostimulation Course in Transcranial Electrical Stimulation at Harvard Medical School in 2019. This course was the first teaching course available in this subject matter.