Hypoglossal Nerve Stimulator Outcomes for Patients Outside the U.S. FDA Recommendations

Objectives The hypoglossal nerve stimulator (HGNS) is currently approved for the treatment of obstructive sleep apnea (OSA) in patients with an apnea‐hypopnea index (AHI) of >15 to ≤65 events/hour, and a central apnea index (CAI) 65 (mean 86.9 events/hour), two had an elevated CAI (mean 31.3% of AHI), and 12 had a BMI >32 kg/m 2 (range 32.1–39.1). Median AHI decreased from 25.3 to 3.75 events/hour on titration polysomnography ( P = .0006), oxyhemoglobin saturation nadir increased from 82% to 88.5% ( P = .0001) and median ESS dropped from 11 to 7.5 ( P = .0016). Fifteen (83.3%) patients achieved surgical success (decrease in AHI >50% and AHI 25% was successfully treated. Median adherence = 33.5 hours/week. Conclusion Our success rate for patients outside the Food and Drug Administration guidelines for HGNS (67%) was similar to the 1‐year STAR trial results (66%). Future studies are necessary to consider expansion of these guidelines. Level of Evidence 4 Laryngoscope , 130:866–872, 2020