{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T23:39:36Z","timestamp":1779925176021,"version":"3.53.1"},"reference-count":42,"publisher":"Cambridge University Press (CUP)","issue":"11","license":[{"start":{"date-parts":[[2023,6,6]],"date-time":"2023-06-06T00:00:00Z","timestamp":1686009600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/www.cambridge.org\/core\/terms"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Laryngol. Otol."],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec id=\"S0022215123000828_sec_a1\"><jats:title>Objective<\/jats:title><jats:p>A retrospective cross-sectional analysis was conducted of the US Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) database, to evaluate the complication profile of cochlear implantation according to manufacturer.<\/jats:p><\/jats:sec><jats:sec id=\"S0022215123000828_sec_a2\" sec-type=\"methods\"><jats:title>Methods<\/jats:title><jats:p>A review of the MAUDE database was conducted from 1 January 2010 to 31 December 2020. Complications, including infection, extrusion, facial nerve stimulation, meningitis and cerebrospinal fluid leak, were identified using key word searches. The categorised data were analysed using a chi-square test to determine a difference in global complication incidence between three major cochlear implant manufacturers: manufacturer A (Cochlear Limited), manufacturer B (Med-El) and manufacturer C (Advanced Bionics).<\/jats:p><\/jats:sec><jats:sec id=\"S0022215123000828_sec_a3\" sec-type=\"results\"><jats:title>Results<\/jats:title><jats:p>A total of 31 857 adverse events were analysed. Implants of manufacturer C were associated with a statistically higher rate of infection (0.97 per cent), cerebrospinal fluid leak (0.07 per cent), extrusion (0.44 per cent) and facial nerve stimulation (0.11 per cent). Implants of manufacturer B were associated with a statistically higher rate of meningitis (0.07 per cent).<\/jats:p><\/jats:sec><jats:sec id=\"S0022215123000828_sec_a4\" sec-type=\"conclusions\"><jats:title>Conclusion<\/jats:title><jats:p>Consideration of patient risk factors along with cochlear implant manufacturers can heighten awareness of cochlear implant complications pre-operatively, intra-operatively and post-operatively.<\/jats:p><\/jats:sec>","DOI":"10.1017\/s0022215123000828","type":"journal-article","created":{"date-parts":[[2023,6,6]],"date-time":"2023-06-06T18:07:35Z","timestamp":1686074855000},"page":"1267-1271","source":"Crossref","is-referenced-by-count":15,"title":["Complications of cochlear implants: a MAUDE database study"],"prefix":"10.1017","volume":"137","author":[{"given":"S","family":"Jinka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1364-1339","authenticated-orcid":false,"given":"S","family":"Wase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8125-279X","authenticated-orcid":false,"given":"A","family":"Jeyakumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2023,6,6]]},"reference":[{"key":"S0022215123000828_ref21","doi-asserted-by":"publisher","DOI":"10.1179\/146701010X12711475887234"},{"key":"S0022215123000828_ref38","first-page":"1278","article-title":"Complications associated with global endometrial ablation: the utility of the MAUDE database","volume":"102","author":"Gurtcheff","year":"2003","journal-title":"Obstet Gynecol"},{"key":"S0022215123000828_ref12","doi-asserted-by":"publisher","DOI":"10.1016\/j.anorl.2013.05.005"},{"key":"S0022215123000828_ref30","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2016.11.001"},{"key":"S0022215123000828_ref7","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0b013e31827d0943"},{"key":"S0022215123000828_ref14","doi-asserted-by":"publisher","DOI":"10.1179\/1754762811Y.0000000025"},{"key":"S0022215123000828_ref4","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjsurg.2010.12.010"},{"key":"S0022215123000828_ref25","first-page":"163","article-title":"Facial nerve stimulation from cochlear implants","volume":"19","author":"Bigelow","year":"1998","journal-title":"Am J Otol"},{"key":"S0022215123000828_ref22","doi-asserted-by":"publisher","DOI":"10.1097\/mao.0b013e318157f80b"},{"key":"S0022215123000828_ref27","doi-asserted-by":"publisher","DOI":"10.1016\/j.otohns.2010.08.011"},{"key":"S0022215123000828_ref10","doi-asserted-by":"crossref","first-page":"1825","DOI":"10.1097\/MLG.0b013e3180de4d35","article-title":"Infectious complications in pediatric cochlear implants","volume":"117","author":"Vila","year":"2007","journal-title":"Laryngoscope"},{"key":"S0022215123000828_ref31","doi-asserted-by":"publisher","DOI":"10.1177\/0145561319864177"},{"key":"S0022215123000828_ref24","doi-asserted-by":"publisher","DOI":"10.1177\/0145561319880625"},{"key":"S0022215123000828_ref11","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-011-1818-1"},{"key":"S0022215123000828_ref6","doi-asserted-by":"publisher","DOI":"10.1001\/archotol.131.3.245"},{"key":"S0022215123000828_ref33","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0000000000000552"},{"key":"S0022215123000828_ref36","doi-asserted-by":"publisher","DOI":"10.1097\/MLG.0b013e3181758154"},{"key":"S0022215123000828_ref39","doi-asserted-by":"publisher","DOI":"10.1002\/lsm.22328"},{"key":"S0022215123000828_ref2","first-page":"CD012023","article-title":"Hearing aids for mild to moderate hearing loss in adults","volume":"2017","author":"Ferguson","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"S0022215123000828_ref16","doi-asserted-by":"publisher","DOI":"10.1016\/j.otohns.2004.02.011"},{"key":"S0022215123000828_ref35","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz649"},{"key":"S0022215123000828_ref32","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0b013e3182544cba"},{"key":"S0022215123000828_ref34","doi-asserted-by":"publisher","DOI":"10.1080\/14670100.2016.1180018"},{"key":"S0022215123000828_ref42","unstructured":"42 The FDA's MAUDE: Useful Insights for Medical Devices. 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