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The ProSomnus® EVO™ [PH] 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™ [PH] Sleep and Snore Device, the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.

The ProSomnus® EVO™ [PH] Sleep and Snore Device consists of maxillary and mandibular device arches 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 connected with the herbst advancer. The device is designed and manufactured using Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) dental technologies, which allows the delivery of a well-fitting, aesthetic, and durable intraoral device for the patient. These devices are digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply rotating the telescopic advancer hex nut or pinhole mechanism in an upward direction to increase the forward positioning of the mandible by smaller increments and according to the physician schedule. Advancements up to 12 mm past the initial bite position may be achieved with additional arches as prescribed by the physician The patient will be able to move the lower jaw forward, side-to-side, and open and close the mouth while wearing the device. The proposed device materials include medical grade polymer, stainless steel herbst arms, and biocompatible adhesive. The device is supplied nonsterile.

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.