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# Innovative Neurological’s Electrotherapy Stimulator Cleared
- URL: https://www.fdaweb.com/innovative-neurologicals-electrotherapy-stimulator-cleared/
- Published: 2019-03-27T12:00:00.000Z
- Updated: 2026-09-15T01:16:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143722

FDA has cleared an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia. The device works by delivering micro pulses of electrical current across a patient’s brain. The company says that clinical studies have demonstrated that the electrical stimulation results in reduced anxiety levels, insomnia, and depressive moods.

Cervella is described by Innovative Neurological as the first cranial electrotherapy stimulator with proprietary conductive treatment electrodes that have been seamlessly integrated into noise-canceling Bluetooth-enabled headphones. “Patients can use the audio and noise cancelling features of the headphones during treatment, which allows them to use the device during study, work, or play,” it says. Additionally, the device is managed through an app on a smart device allowing for automated treatment data recording, reminders, and analytics aimed at improving patient treatment outcomes.