Genesis Sleep

Genesis Sleep is a non-invasive, battery-powered neurostimulation device indicated to treat chronic insomnia in adults aged 22 and older for both clinical and home use. It delivers low-level electrical stimulation (up to 1 mA) transcutaneously to the vestibular nerves via two self-adhesive electrode pads placed behind the ears over the mastoid processes, using a technology called electrical vestibular nerve stimulation (VeNS). The device can be controlled via PC-based software, and intensity is adjustable by the user.

Genesis Sleep uses a 12 V Li-Ion battery with DC:DC converter isolation, delivers symmetrical biphasic rectangular waveforms at 0.25 Hz frequency with 0–1000 µA current intensity, 2-second pulse duration, and 4-second primary phase duration. Compared to the predicate Modius Sleep, key differences include PC-based software controls (versus built-in buttons), extruded aluminum enclosure (versus plastic), higher patient leakage current (0.8 µA versus 0 µA but within safe limits), better single fault condition performance (0.54 µA versus 2.3 µA), and an automatic overload trip feature. All stimulation output parameters, waveforms, frequencies, electrode placement, and safety specifications are otherwise identical.

The device complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and additionally IEC 60601-1-11 (home environment safety). Software validation and verification comply with FDA guidance requirements. Biocompatibility compliance with ISO 10993 is demonstrated.

Genesis Sleep is substantially equivalent to the predicate Modius Sleep (K230826) because both are non-invasive cranial electrotherapy stimulators with identical regulatory class (Class II), product code (QJQ), intended use (treating chronic insomnia in adults 22+), and all critical stimulation parameters (waveform, frequency, current intensity, pulse duration, burst mode, electrode placement). Minor differences in form factor, enclosure material, and control interface (PC-based versus built-in) do not alter the stimulation output, electrode interface, or treatment protocol. The predicate's clinical data from a sham-controlled trial demonstrating safety and efficacy directly applies to Genesis Sleep since the delivered therapy is identical, and the device has undergone comparative performance testing confirming identical output under multiple load conditions.