FDA OKs Brain Stimulator for Insomnia, Anxiety, Depression

Megan Brooks

March 27, 2019

The US Food and Drug Administration (FDA) has approved a cranial electrotherapy stimulator (Cervella, Innovative Neurological Devices) for treatment of anxiety, depression, and insomnia, the company has announced.

Cervella, which requires a prescription, delivers micro pulses of electrical current across the brain, which in clinical trials led to a reduction in anxiety levels, insomnia, and depressed mood, the company said in a news release.

Cervella is the first cranial electrotherapy stimulator (CES) with proprietary conductive treatment electrodes that have been seamlessly integrated into noise-cancelling, Bluetooth-enabled headphones, the company said.

It's also the first CES device that is managed through an app on a smart device, allowing for automated treatment data recording, reminders, and analytics aimed at improving patient treatment outcomes.

"For many years, CES devices have been clinically validated as a safe and effective alternative to drug-based therapies without the side effects that often exist with the use of antidepressants," Bart Waclawik, president and CEO of Innovative Neurological Devices, said in the release. "We hope that by incorporating treatment electrodes into a noise-cancelling headset, patient compliance will significantly increase and, consequently, treatment outcomes will improve."

Because the Cervella device looks like ordinary headphones, "patients will have the freedom to use the device in anxiety-inducing situations without curious looks from onlookers," said Waclawik. The automated data aggregation available through the proprietary Cervella app gives a patient an option to easily share treatment data with his or her health provider in order to better manage the treatment plan, added Waclawik.

Cervella will be available in the US at the introductory price of $695 and will be launched at the Anxiety and Depression Conference in Chicago tomorrow. More information on the device is available online.

Correction: An earlier version of this story incorrectly indicated that the introductory price of Cervella was $69. It is $695.

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