Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.

Inclusion Criteria:

1. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship,under curatorship or under judicial protection.

2. Body mass index (BMI) ≤ 32 kg/m2. 3. Positive cricomental space (≥ 0 cm). Thecricomental space is the distance between the neck and the bisection of a linefrom the chin to the cricoid membrane when the head is in a neutral position.

3. Has either not tolerated, has failed or refused positive airway pressure (PAP)treatments.

4. Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI<25% ofthe total AHI) based on a screening HST and confirmed in Baseline PSG.

5. Complete concentric collapse at the level of the soft palate based on screeningDISE.

6. Willing and capable of complying with all study requirements, includingspecific lifestyle considerations, performing all follow-up visits and sleepstudies, evaluation procedures and questionnaires for the whole duration of thetrial.

• Exclusion Criteria:

1. Inadequately treated sleep disorders other than OSA that would confoundfunctional sleep assessment:

2. Severe chronic insomnia,

3. Insufficient sleep syndrome (<6 hours sleep per night),

4. Narcolepsy,

5. Restless legs syndrome,

6. REM behavior disorder,

7. Others deemed sufficient disorders that would confound functional sleepassessment in the judgment of the investigator.

8. Taking medications that may alter consciousness, the pattern of respiration, orsleep architecture as determined by the investigator.

9. Major anatomical or functional abnormalities that would impair the ability ofthe Genio® System to treat OSA:

10. Craniofacial abnormalities narrowing the airway or the implantation site,

11. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,

12. Fixed upper airway obstructions (tumor, polyps, nasal obstruction),

13. Congenital malformations in the airway,

14. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateralunintended tongue deviation during protrusion),

15. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10questionnaire

16. Others deemed sufficient to impair the ability of the Genio® System totreat OSA in the judgment of the investigator.

17. Significant comorbidities that contraindicate surgery or general anesthesia:

18. Revised Cardiac Risk Index Class III or IV,

19. Persistent uncontrolled diagnosed hypertension despite medications,

20. Coagulopathy or required anticoagulant or antiplatelet medications (suchas warfarin, clopidogrel (Plavix) or similar; prophylactic aspirin notexclusionary) that cannot be safely stopped in the perioperative period,Subjects meeting any of the following criteria will be excluded fromparticipation in this study:

21. Inadequately treated sleep disorders other than OSA that would confoundfunctional sleep assessment:

22. Severe chronic insomnia,

23. Insufficient sleep syndrome (<6 hours sleep per night),

24. Narcolepsy,

25. Restless legs syndrome,

26. REM behavior disorder,

27. Others deemed sufficient disorders that would confound functional sleepassessment in the judgment of the investigator.

28. Taking medications that may alter consciousness, the pattern of respiration, orsleep architecture as determined by the investigator.

29. Major anatomical or functional abnormalities that would impair the ability ofthe Genio® System to treat OSA:

30. Craniofacial abnormalities narrowing the airway or the implantation site,

31. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,

32. Fixed upper airway obstructions (tumor, polyps, nasal obstruction),

33. Congenital malformations in the airway,

34. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateralunintended tongue deviation during protrusion),

35. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10questionnaire

36. Others deemed sufficient to impair the ability of the Genio® System totreat OSA in the judgment of the investigator.

37. Significant comorbidities that contraindicate surgery or general anesthesia:

38. Revised Cardiac Risk Index Class III or IV,

39. Persistent uncontrolled diagnosed hypertension despite medications,

40. Coagulopathy or required anticoagulant medications (such as warfarin,clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary)that cannot be safely stopped in the perioperative period,

41. Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer'sdisease),

42. Acute illness or infection,

43. Any other chronic medical illness or condition that contraindicates asurgical procedure or general anesthesia in the judgment of theinvestigator.

44. Diagnosed psychiatric disease (e.g., psychotic illness, uncontrolled majordepression or acute anxiety attacks) that prevents participant compliance withthe requirements of the investigational study testing,

45. Substance or alcohol abuse history within the previous 3 years. Alcohol andsubstance abuse are defined as follows: i. Alcohol: no days with less than 3 or 4 standard drinks for women and menrespectively ii. Substance: the use of any substance in an amount unapproved bythe investigator or considered illegal. The drugs most commonly abused includecocaine, marijuana, heroin (or substitution treatment), prescription drugs (especially painkillers), methamphetamines, and various other illegalsubstances.

46. Life expectancy of less than 12 months.

47. Prior surgery or treatments that could compromise the effectiveness of theGenio® System:

48. Airway cancer surgery or radiation,

49. Mandible or maxilla surgery in the previous 5 years (not counting dentaltreatments),

50. Other upper airway surgery to remove obstructions related to OSA in theprevious 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy,nasal airway surgery),

51. Prior hypoglossal nerve stimulation device implantation.

52. Has an Active Implantable Medical Device (AIMD) even if the device can betemporarily turned off.

53. Participation in another clinical study with an active treatment arm.

54. Plan to become pregnant, currently pregnant, or breastfeeding during the studyperiod.