FDA Clears External Craniostimulation Device for Treatment of Insomnia, Anxiety, and Depression

Thursday, March 28, 2019


The Food and Drug Administration (FDA) has cleared a novel cranial electrostimulation (CES) device (Cervella; Innovative Neurological Devices, Carmel, IN). Proprietary electrodes that deliver CES are integrated into a noise-cancelling Bluetooth headset to deliver CES, which is indicated for treatment of insomnia, anxiety, and depression. Multiple clinical studies have shown CES to be safe and effective for treatment of these conditions, and other devices are available. 

Unique to this device is the delivery via headphones that can be used to cancel noise or listen to audio during treatment. In this manner, the device and treatment can fit more seamlessly into the user’s lifestyle.

Approved for adults and adolescents, the device was designed not only to fit into patient’s lives more easily but also to allow for more discrete treatment across multiple settings. This meets a need expressed by patients not to stand out or have treatment be obvious to others. It is expected that the appearance and seamless integration of therapy into varied lifestyles will increase adherence to treatment. 

Treatment with the device requires a prescription and is managed through an app on a phone or tablet, which also allows clinicians and patients to set automated treatment reminders, record treatment data, and see analytics regarding effects of treatment. 

The device is being launched today at the Anxiety and Depression Conference in Chicago and will be available for $695.  

Bart Waclawik, President and CEO of Innovative Neurological Devices said, "We hope that by incorporating treatment electrodes into a noise-cancelling headset, patient compliance will significantly increase and, consequently, treatment outcomes will improve. Also, by making the Cervella device appear indistinguishable from ordinary over-ear headphones, patients will have the freedom to use the device in anxiety-inducing situations without curious looks from onlookers. Last but not least, 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." 

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