Non-Randomized, Multi-Site, Single-Arm Study of the LinguaFlex™ Tongue Retractor (LTR) for the Treatment of Moderate to Severe Obstructive Sleep Apnea and Snoring in Adult Subjects
The LinguaFlex™ Tongue Retractor (LTR) is an investigational medical device that is inserted into the tongue to lessen its backward movement during sleep. This helps to keep the airway open during sleep so that the tongue doesn't block the airway causing obstructive apnea or narrow it enough to cause snoring. This study will monitor the effectiveness of the LTR device in the reduction of Obstructive Sleep Apnea and snoring over the course of a one-year treatment period.
• Subjects able to read, understand and sign consent
• Subjects 18 years or older with:
‣ Moderate to severe OSA (AHI of ≥ 15 to ≤ 50 as determined by a Diagnostic PSG recording within 2 months of inclusion)
⁃ Subject agrees not to use any type of additional OSA therapy including PAP therapy throughout the course of the study