Assessment of OSA in Latin American and Response to Neuromod Therapy

Inclusion Criteria:

1. Subject is aged ≥ 18 years old

2. Subject is willing and able to provide informed consent

3. Subject is geographically stable

4. Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and/or behavioral treatments)

5. Subject has an Apnea-Hypopnea Index (AHI) score ≥15 < 100 events per hour onScreening PSGs (under AASM 4%) based on in-lab polysomnography studies

Exclusion Criteria:

1. Subject is currently implanted with another active implantable device.

2. Subject is actively enrolled in another premarket investigational study (medicaldevice or drug) unless approved by Sponsor in writing.

3. Subject is considered vulnerable such as incarcerated or cognitively impaired.

4. Subject is taking opioids, narcotics, sleep or psychotic medications or supplementsthat in the opinion of the investigator may alter consciousness, the pattern ofrespiration, sleep architecture, or with known effect on sleep-wake function oralertness.

5. Any reason for which, in the judgment of the investigator, the subject is consideredto be a poor study candidate, which may include, but is not limited to: anyuncontrolled neurological, medical, social, or psychological problems that couldcomplicate the required procedures and evaluations of the study ((e.g. uncontrolledhypertension, unstable angina, uncompensated heart failure or COPD, majordepression, Parkinson's disease, epilepsy)

6. Subject has previous upper respiratory tract (URT) surgery (e.g., uvula, soft palateor tonsils) within 60 days prior to Screening PSG.

7. Subject has a need for chronic supplemental oxygen therapy for any reason or a PaO2 <70 mm Hg

8. Subject has other sleep disorders or sleep hygiene behaviors that confoundfunctional assessments of sleepiness and/or overnight PSG Study outcomes (e.g.Narcolepsy with cataplexy, idiopathic hypersomnolence, insomnia, REM sleep behaviordisorder, or sleep movement disorders, such as restless leg syndrome or periodiclimb movement, producing sleep disturbances unrelated to OSA.)

9. Subject has severe chronic kidney disease (GFR < 30)

10. Subject has currently excessive use of alcohol, tobacco, caffeine, or recreationaldrugs.

11. Subject is unwilling or unable to refrain from consumption of alcoholic beveragesfor 24 hours prior to the start of each PSG study.

12. Subject has a BMI > 40 kg/m2

13. Subject has an active systemic infection

14. If female, subject is pregnant at the time of enrollment or planning to becomepregnant during the study time period (must have a negative serum or urine pregnancytest within 14 days prior to enrollment)

15. Subject has a tonsil size 3 or 4 based on the tonsil grading system

16. Subject has documented history of Phrenic nerve palsy or asymmetry of the diaphragm

17. Subject has any trauma to the upper airway that interferes with limited tonguemovement or inability to move the tongue, tongue dysfunction, atrophy, hypertrophy,fasciculation, or problems swallowing or speaking

18. Subject has severe mandibular deficiency/retrognathia or syndromic craniofacialabnormalities.

19. Subject has previous surgical resection or radiation therapy for cancer orcongenital malformations in the larynx, tongue, or throat.

20. Subject has an oxygen saturation (SaO2) >10% falls index > 15 events per hour onScreening PSGs

21. Subject has >25% central apnea events as a proportion of the sum of apnea andhypopnea events per hour on Screening PSGs (up to 3 patients with CAI+MAI ≥ 25% maybe included)

22. Subject has sleep Efficiency < 80%