Hyoid SuspensionHyoid Suspension to the Mandible for the Treatment of Obstructive Sleep Apnea

Inclusion Criteria:

1. Documented diagnosis of moderate or severe obstructive sleep apnea (AHI between 20 and 60/hour) evaluated with a sleep study within 12 months prior to the planned procedure
2. Age ≥ 20 and ≤ 65 years old
3. Body Mass Index (BMI) ≤ 36 (kg/m2)
4. Patient has been offered CPAP and has refused or failed to continue CPAP treatment or is noncompliant with CPAP
5. Significant airway narrowing while mild posterior is pressure applied to hyoid bone
6. Evidence of hypopharyngeal obstruction via pharyngoscopy
7. Signed informed consent to participate in this clinical study

Exclusion Criteria:

Patient History

1. Prior OSA surgery (uvulopalatopharyngoplasty \[UPPP\], tonsillectomy and nasal surgery are acceptable)
2. Active systemic infection
3. Allergy to any medication used during implantation
4. Previous history of neck or upper respiratory tract cancer
5. Radiation therapy to neck or upper respiratory tract
6. Significant dysphagia or speech disorder Anatomical Considerations

1. Identified obvious palatal stenosis 2. Enlarged tonsils (3+) 3. Anatomy unable to accommodate the implant

Other

1. Other medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving this treatment, as well as the procedures and evaluations pre- and post-treatment
2. Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
3. Unable and/or not willing to comply with treatment follow-up requirements
4. Pregnancy (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment.)
5. Lack of insurance coverage for procedure and PSG follow up and unwillingness to self pay
6. Unwilling or unable to give signed informed consent