Lead Sponsor

Invicta Medical Inc.

Collaborators

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

•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.

•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.