Between October 2016 and January 2018, 508 participants were enrolled from 14 centers. Median AHI was reduced from 34.0 to 7.0 events/h, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. Therapy adherence was 5.7 ± 2.2 hours/week at 12-months. The implantation procedure was safe, with 98% procedures completed without adverse events. Improvement measured by the physician clinical global impression scale was seen in 93% of patients, and 94% of patients reported they were overall satisfied with UAS therapy. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1 unit increase in BMI, there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as a statistically significant predictor of treatment success.