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The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device. the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.

The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible. The ProSomnus® EVO Sleep and Snore Device and the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are CAD/CAM designed with twin-mated posts and are digitally milled to be patient-specific according to physician prescription. Customizable ergonomic features are available to improve patient comfort. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile. A micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring. The micro-recorder is a compliance sensor, which logs the time the device is worn.