The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
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Incidence of device-related Serious Adverse Events (SADEs)
Timeframe: 12 months post-surgery
Change in Apnea-Hypopnea Index from baseline
Timeframe: 12 months post-surgery
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire
Timeframe: 12 months post-surgery