{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T01:13:41Z","timestamp":1783041221905,"version":"3.54.6"},"reference-count":26,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,7,10]],"date-time":"2019-07-10T00:00:00Z","timestamp":1562716800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>The hypoglossal nerve stimulator (HGNS) is currently approved for the treatment of obstructive sleep apnea (OSA) in patients with an apnea\u2010hypopnea index (AHI) of\u2009&gt;15 to \u226465 events\/hour, and a central apnea index (CAI)\u2009&lt;25% of the AHI, no complete concentric collapse on drug\u2010induced sleep endoscopy, and a recommended body mass index (BMI)\u2009&lt;32 kg\/m<jats:sup>2<\/jats:sup>. We present 18 patients implanted as a salvage procedure despite being outside these guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We included all patients who underwent HGNS but who did not meet all FDA guidelines. Demographic data, previous OSA treatments, polysomnographic (PSG) parameters from baseline and HGNS titration PSG, Epworth sleepiness score (ESS), and BMI were compared before and after surgery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eighteen patients were identified: 94.4% male, median age 63 years. Seven underwent previous sleep surgery. Four had an AHI\u2009&lt;15 (mean 10.5 events\/hour), four had an AHI\u2009&gt;65 (mean 86.9 events\/hour), two had an elevated CAI (mean 31.3% of AHI), and 12 had a BMI\u2009&gt;32 kg\/m<jats:sup>2<\/jats:sup> (range 32.1\u201339.1). Median AHI decreased from 25.3 to 3.75 events\/hour on titration polysomnography (<jats:italic>P\u2009=<\/jats:italic> .0006), oxyhemoglobin saturation nadir increased from 82% to 88.5% (<jats:italic>P\u2009=<\/jats:italic> .0001) and median ESS dropped from 11 to 7.5 (<jats:italic>P\u2009=<\/jats:italic> .0016). Fifteen (83.3%) patients achieved surgical success (decrease in AHI\u2009&gt;50% and AHI\u2009&lt;20 events\/hour) and 12 (66.7%) had an AHI\u2009&lt;5 events\/hour. Neither patient with CAI\u2009&gt;25% was successfully treated. Median adherence = 33.5 hours\/week.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our success rate for patients outside the Food and Drug Administration guidelines for HGNS (67%) was similar to the 1\u2010year STAR trial results (66%). Future studies are necessary to consider expansion of these guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>4 <jats:italic>Laryngoscope<\/jats:italic>, 130:866\u2013872, 2020<\/jats:p><\/jats:sec>","DOI":"10.1002\/lary.28175","type":"journal-article","created":{"date-parts":[[2019,7,10]],"date-time":"2019-07-10T15:05:03Z","timestamp":1562771103000},"page":"866-872","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Hypoglossal Nerve Stimulator Outcomes for Patients Outside the U.S. FDA Recommendations"],"prefix":"10.1002","volume":"130","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0536-8886","authenticated-orcid":false,"given":"Kathleen M.","family":"Sarber","sequence":"first","affiliation":[{"name":"Division of Pulmonary Medicine Cincinnati Children's Hospital Medical Center  Cincinnati Ohio U.S.A."},{"name":"Division of Pediatric Otolaryngology Head and Neck Surgery Cincinnati Children's Hospital Medical Center  Cincinnati Ohio U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine W.","family":"Chang","sequence":"additional","affiliation":[{"name":"University of Cincinnati College of Medicine  Cincinnati OH U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0997-9692","authenticated-orcid":false,"given":"Stacey L.","family":"Ishman","sequence":"additional","affiliation":[{"name":"Division of Pediatric Otolaryngology Head and Neck Surgery Cincinnati Children's Hospital Medical Center  Cincinnati Ohio U.S.A."},{"name":"Department of Otolaryngology\u2013Head &amp; Neck Surgery University of Cincinnati College of Medicine  Cincinnati OH USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madison V.","family":"Epperson","sequence":"additional","affiliation":[{"name":"University of Cincinnati College of Medicine  Cincinnati OH U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reena","family":"Dhanda Patil","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head &amp; Neck Surgery University of Cincinnati College of Medicine  Cincinnati OH USA"},{"name":"Department of Otolaryngology Cincinnati Veterans Affairs Medical Center  Cincinnati Ohio U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,10]]},"reference":[{"issue":"4","key":"e_1_2_6_2_1","first-page":"1","article-title":"Obstructive sleep apnea and obesity: implications for public health","volume":"1","author":"Jehan S","year":"2017","journal-title":"Sleep Med Disord"},{"key":"e_1_2_6_3_1","first-page":"1053","article-title":"Functional electrical stimulation and respiration during sleep","volume":"75","author":"Decker MJ","year":"1993","journal-title":"J Appl Phys"},{"key":"e_1_2_6_4_1","first-page":"129","article-title":"Effect of upper\u2010airway stimulation for obstructive sleep apnoea on airway dimensions","author":"Safiruddin F","year":"2014","journal-title":"Eur Respir J"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.23301"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1308659"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.2658"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.5972"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.5888\/pcd14.160365"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.2260"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1532-5415.2001.49238.x"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.3444"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/33.11.1495"},{"key":"e_1_2_6_14_1","volume-title":"The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications","author":"Berry RB","year":"2012"},{"key":"e_1_2_6_15_1","first-page":"435","article-title":"Defining least burdensome means under the Food And Drug Administration Modernization Act Of 1997","volume":"55","author":"Smith JJ","year":"2000","journal-title":"Food & Drug LJ"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599814544445"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.26178"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.27426"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoto.2018.4077"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1159\/000222508"},{"key":"e_1_2_6_21_1","volume-title":"Kryger MH, Roth T. 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