A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults

Inclusion Criteria:

• Body Mass Index (BMI) < 35 kg/m2

• AHI between 15 to 65 events/hour documented by the closest PSG performed at the timeof the patient ICF signature and within maximum 12 months of screening andfulfilling the required technical criteria or during the screening phase.

• Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) orMandibular Advancement Device (MAD) treatments.

Exclusion Criteria:

• Inadequately treated sleep disorders other than OSA that would confound functionalsleep assessment;

• Taking medication that in the opinion of the Investigator may alter consciousness,the pattern of respiration, or sleep architecture;

• Major anatomical or functional abnormalities that would impair the ability of theGenio® system to treat OSA;

• Inadequately treated psychiatric disease that prevent patient compliance with therequirements of the investigational study testing;

• Life expectancy < 12 months;

• Participation in another clinical study (excluding registries) during the studyperiod (3 years).