An Extension Study to Assess the Long-term Safety of the Genio® System

"All participants have previously been implanted with a Genio® system implantable stimulator. This research is observational in nature (long term safety follow-up) and participants will not be exposed to additional procedures.~The Genio System comprises of a bilateral Implantable Stimulator (IS), which is implanted via a minimally invasive surgery procedure and positioned over the genioglossus muscle with its electrodes positioned over both the left and right hypoglossal nerve branches. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway. The Implantable Stimulator receives energy pulses transmitted via the DP placed under the patient's chin and connected to the Activation Chip (AC), which contains the patient's stimulation parameters and contain a battery that provides energy."