Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.

Inclusion Criteria: * Subject must be eligible for an OSA diagnostic or surgical procedure. * Subject suffers with moderate to severe OSA based on history and a physical exam. * Subject has failed, refused or has not tolerated CPAP treatment. * Subject is willing and capable of providing informed consent. * Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space. --Subject is willing to participate in the designated follow-up visits. * Subject must be in good general health. * Subject is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure. * Subject must be minimum of 21 years and maximum 80 years of age. * Subject's Hypoglossal Nerve must be able to be visualized using ultrasound Exclusion Criteria: * Subject has Body Mass Index above 38kg/m2. * Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat. * Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study. * Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.