LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults

Inclusion Criteria:

• Subjects able to read, understand and sign consent

• Subjects 18 years or older with:

1. Moderate to severe OSA (AHI of ≥ 15 to ≤ 50 as determined by a Diagnostic PSGrecording within 2 months of inclusion)

2. Subject agrees not to use any type of additional OSA therapy including PAPtherapy throughout the course of the study

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in the clinical trial:

• < 18 years of age

• AHI < 15(mild OSA)

• AHI > 50

• Subjects with > 20% of AHI score accounted for from central apnea

• More than 10% of Total Sleep Time (TST) with blood O2 saturation (SaO2) below 70%

• Subjects successfully treated with prescribed PAP therapy

• Tonsillar hypertrophy ≥3

• Subjects with significant active comorbid respiratory or cardiac disease (such asCOPD or Heart Failure)

• Subjects requiring regular use of supplemental oxygen

• Nasal airway obstruction as seen on examination

• Congenital malformations of the upper airway, larynx, pharynx, oral cavity or tongue

• Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen onexamination (suspected epiglottic obstruction)

• History of radiation therapy to the neck or upper respiratory tract

• Subjects with bleeding disorders, unresolved impaired immunity for any reason, orheart attack within the last six months

• Subjects with an existing tongue stud/piercing

• Females who are pregnant (anesthesia risk)

• Allergy to LTR materials (Silicone, PEEK, Polyurethane)

• Subjects who have in the surgeon's judgment unusual anatomy that would interferewith treatment or increase the risk for the procedure

• Unable and/or unwilling to comply with study requirements