Evaluation of the Effects 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 a diagnostic or surgical procedure and * Suffers from OSA (apnea/hypopnea index \>10 event/h sleep) based on history and a physical exam. * Is a surgical candidate. * Is willing and capable of providing informed consent. * Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space. * Is willing to participate in the designated follow-up visits. * Must be in good general health. * 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. * Must be minimum of 18 years and maximum 80 years of age. Exclusion Criteria: * Has Body Mass Index above 35 kg/m2. * Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat. * Has significant co-morbidities making them unable or inappropriate to participate in this POC study.