Tongue Advancement for Obstructive Sleep Apnea

Exclusion Criteria

• •Prior OSA surgery except tonsillectomy, nasal surgery and uvulopalatopharyngoplasty; no airway surgery within 3 months prior to enrollment.
• •Airway collapse at the level of the soft palate (palatal collapse).
• •Enlarged tonsils (3+ and 4+)
• •Anatomy unable to accommodate the implant
• •Severe mandibular deficiency/retrognathia
• •Unable and/or not willing to comply with treatment follow-up requirements.
• •Pregnancy. (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study)
• •Breastfeeding women
• •Active systemic infection
• •Allergy to any medication used during implantation
• •Previous history of neck or upper respiratory tract cancer
• •History of radiation therapy to neck or upper respiratory tract
• •Dysphagia
• •Major cardiovascular and pulmonary disorders
• •Other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment
• •Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study