{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T12:19:51Z","timestamp":1768565991309,"version":"3.49.0"},"reference-count":32,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2015,11,24]],"date-time":"2015-11-24T00:00:00Z","timestamp":1448323200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"German Ministry of Education","award":["01EZ0335"],"award-info":[{"award-number":["01EZ0335"]}]},{"name":"The SRH foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:sec><jats:title>Objectives\/Hypothesis<\/jats:title><jats:p>To evaluate the performance and safety of the newly developed Laryngeal Pacemaker System (LP System) for the treatment of bilateral vocal fold paralysis (BVFP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design<\/jats:title><jats:p>Feasibility, first\u2010in\u2010human, single\u2010arm, open\u2010label, prospective, multicenter study with a group sequential design and a 6\u2010month follow\u2010up period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Nine symptomatic BVFP subjects were implanted unilaterally with the LP System. Pre\u2010 and 6\u2010month postimplantation evaluations consisted of the 6\u2010Minute Walk Test (6MWT), the Peak Expiratory and Inspiratory Flow (PEF and PIF) evaluation, the PEF meter analysis, the 36\u2010Item Short Form Health Survey (SF\u201036), the Glasgow Benefit Inventory (GBI), the 12\u2010Item Voice Handicap Index (VHI\u201012), and the Fiberoptic Endoscopic Evaluation of Swallowing. The safety profile of the LP System was continuously monitored.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The LP System implantation was achieved in 8\/9 cases. Seven of the nine subjects completed the study. Absolute PEF and PIF values improved significantly 6 months postimplantation (<jats:italic>P<\/jats:italic>&lt; .05). 6MWT results showed a non\u2013statistically significant improvement (<jats:italic>P<\/jats:italic>= .09). The mental component of the SF\u201036 showed a significant improvement (<jats:italic>P<\/jats:italic>= .043), whereas the other SF\u201036 components, the GBI, and the VHI\u201012 results did not changed significantly. The LP System did not affect the voice and swallowing quality and maintained a reliable safety profile for the duration of the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This feasibility study showed that the LP System has the potential to become an effective and safe treatment for BVFP subjects without compromising the patients' voice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>2b<jats:italic>Laryngoscope<\/jats:italic>, 126:1810\u20131816, 2016<\/jats:p><\/jats:sec>","DOI":"10.1002\/lary.25792","type":"journal-article","created":{"date-parts":[[2015,11,24]],"date-time":"2015-11-24T14:17:57Z","timestamp":1448374677000},"page":"1810-1816","source":"Crossref","is-referenced-by-count":56,"title":["Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first\u2010in\u2010human study"],"prefix":"10.1002","volume":"126","author":[{"given":"Andreas H.","family":"Mueller","sequence":"first","affiliation":[{"name":"Department of Otorhinolaryngology SRH Wald\u2010Klinikum Gera Gera Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rudolf","family":"Hagen","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology University of Wuerzburg Wuerzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerhard","family":"Foerster","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology SRH Wald\u2010Klinikum Gera Gera Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wilma","family":"Grossmann","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology University of Wuerzburg Wuerzburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katrin","family":"Baumbusch","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology Innsbruck University Hospital Innsbruck Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claus","family":"Pototschnig","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology Innsbruck University Hospital Innsbruck Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,11,24]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-008-0665-1"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.otohns.2005.08.028"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.21003"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-013-2414-3"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/archoto.2007.44"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.20698"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/MOO.0b013e32834cb7ba"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1308659"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005537-200307000-00010"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348940010900405"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-012-2036-1"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-012-2141-1"},{"key":"e_1_2_7_14_1","first-page":"47","article-title":"Laryngeal neuroprothesis","volume":"21","author":"Mueller AH","year":"2012","journal-title":"ENT Audiol News"},{"key":"e_1_2_7_15_1","doi-asserted-by":"crossref","DOI":"10.1055\/b-001-3179","volume-title":"Lungenfunktions\u2010Manual : nach den Richtlinien der Deutschen Gesellschaft f\u00fcr Pneumologie","author":"Ulmer WT","year":"2004"},{"key":"e_1_2_7_16_1","first-page":"919","article-title":"The 6\u2010minute walk: a new measure of exercise capacity in patients with chronic heart failure","volume":"132","author":"Guyatt GH","year":"1985","journal-title":"Can Med Assoc J"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00194909"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00417897"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(98)00081-X"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348949610500601"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00106-003-0909-8"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.25137"},{"key":"e_1_2_7_23_1","unstructured":"International Organization for Standardization. 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