A headset and a phone app are now part of the FDA’s approved options for treating some cases of major depression in the United States.
Late last year, the U.S. Food and Drug Administration approved Flow FL-100, an at-home brain stimulation device developed by Flow Neuroscience, for particular cases of major depressive disorder. The approval makes brain stimulation treatment available at home and adds a non-drug option for depression care.
“This is a monumental step forward for the millions of Americans struggling w/ depression. The FDA approval marks the first time in history American clinicians are able to prescribe a novel at-home, non-drug therapy as both a stand-alone and adjunctive treatment for adults w/MDD,” Flow Neuroscience posted on social media shortly after the federal approval.
According to the FDA’s summary of safety and effectiveness data, Flow FL-100 is a headset that connects to a smartphone by Bluetooth. Patients use an app that provides guidance, controls the headset and tracks its usage.
The headset uses transcranial direct current stimulation, or tDCS. It sends low-intensity direct electrical current through electrodes on the scalp to parts of the brain. “The electrical current may modulate neuronal activity by altering the resting membrane potential of cortical neurons, thereby influencing brain excitability,” the FDA summary says.
According to the New York Times’ Rachel Gross, neuromodulation is based on the idea that depression involves impaired neural connectivity. Researchers theorize that electrical brain stimulation makes it easier for neurons to fire, contributing to improving the depressed brain’s general functioning.
“Ultimately, we’re trying to get into the brain and tickle neurons,” Mark George, a psychiatrist at the Medical University of South Carolina, told the Times. The outlet reported that he consulted for a home-based brain neuromodulation system that was also approved last year.
Before Flow FL-100, the FDA had cleared two other non-invasive brain stimulation treatments for depression, according to an editorial in the journal Brain Stimulation: repetitive transcranial magnetic stimulation and electroconvulsive therapy. Both could only be delivered in a clinic.
“So, the FDA approval of at-home brain-stimulation expands access and enables treatment for depressed patients who would otherwise be unable or unwilling to receive clinic-based therapies,” the editorial’s authors wrote.
Electroconvulsive therapy dates back decades as a treatment for depression. Developed in Italy in the 1930s, it induces brief seizures in patients under anesthesia. tDCS does not induce seizures.
As medical historian Jonathan Sadowsky wrote for The Conversation in 2017, “many psychiatrists, and more importantly, patients, consider it to be a safe and effective treatment for severe depression and bipolar disorder.”
The source text says public stigma around electroconvulsive therapy has been reinforced by popular culture, including the 1970s film One Flew Over the Cuckoo’s Nest. It says the novel by Ken Kesey was published in 1962 and was based on his volunteer work at a Veterans’ Affairs hospital. It was adapted into a 1975 film by Milos Forman that won four major Academy Award categories the following year, including Best Actress for Louise Fletcher as nurse Mildred Ratched.
The FDA approval was largely based on a 2024 Nature Medicine clinical trial that, according to the researchers, “showed high efficacy, acceptability and safety.” But the Brain Stimulation editorial said the difference in average Hamilton Depression Rating Scale point reduction between the treatment group, about 9, and the sham group, about 2, is “sometimes considered below a clinically meaningful difference.”
Flow FL-100 was approved for adults with moderate to severe major depressive disorder whose depression has not been resistant to medication such as Prozac. The FDA recommended that the device be used either instead of medication or alongside it.
According to the Times, side effects “include ringing in the ears, headaches and mild burns or irritation where the electrode pads touched the forehead.”
Erin Lee, Flow Neuroscience’s CEO, told Reuters’ Kamal Choudhury in December that the company is aiming for a U.S. retail price of between $500 and $800 when the device reaches the market later this year. The device has been approved as a depression therapy in England since 2019.
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