{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:49:35Z","timestamp":1786978175960,"version":"build-2736575974"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,2,6]],"date-time":"2025-02-06T00:00:00Z","timestamp":1738800000000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Laryngoscope Investig Oto"],"published-print":{"date-parts":[[2025,2]]},"abstract":"Abstract<\/jats:title>\n \n Objective<\/jats:title>\n Identify MRI\u2010related cochlear implant (CI) adverse events from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database and determine whether devices with diametric magnets are associated with reduced adverse events.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Data on MRI\u2010related adverse events were collected from the MAUDE database for reports filed between 01\/01\/2013 and 01\/29\/2023. Outcomes and interventions were manually extracted. Device problems, electrode designs, and correlated patient problems were grouped and analyzed using R.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n All CI complications were derived from three manufacturers: Cochlear Limited, Advanced Bionics, and MED\u2010EL. MRI\u2010related CI complications occurred in 668 of 32,446 reports (2.1%). MRI\u2010related CI complications increased from 32 reports (4.8%) in 2013 to a peak of 142 reports (21.3%) in 2019 and decreased to 56 reports (8.4%) in 2022. The most common MRI\u2010related device problems were dislodgment\/dislocation (39.9%,\n n<\/jats:italic>\n \u2009=\u2009266) or migration\/expulsion (33.4%,\n n<\/jats:italic>\n \u2009=\u2009223). The most frequently identified patient problems identified were pain (31.6%,\n n<\/jats:italic>\n \u2009=\u2009211), hearing impairment (4.9%,\n n<\/jats:italic>\n \u2009=\u200933), unspecified medical problems (3.7%,\n n<\/jats:italic>\n \u2009=\u200925), implant failure (3.0%,\n n<\/jats:italic>\n \u2009=\u200920), and injury (1.5%,\n n<\/jats:italic>\n \u2009=\u200910). Of these, 358 reports (53.6%) contained the date of device manufacture. The median MDR per year decreased from 11 in the 3\u2009years before each manufacturer released their MRI\u2010conditional CI to 0 in the 3\u2009years following the release (\n p<\/jats:italic>\n \u2009=\u20090.014).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The introduction of MRI\u2010conditional CIs has successfully reduced MRI\u2010associated adverse events. There have been no reported cases of MRI\u2010related CI complications for devices containing the new MRI\u2010conditional magnets for each of the three major US manufacturers.<\/jats:p>\n <\/jats:sec>\n \n Level of evidence<\/jats:title>\n N\/A<\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/lio2.70073","type":"journal-article","created":{"date-parts":[[2025,2,6]],"date-time":"2025-02-06T07:36:52Z","timestamp":1738827412000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A comprehensive analysis of\n MRI<\/scp>\n \u2010related Cochlear implant adverse events reported by\n FDA<\/scp>\n 's manufacturer and user facility device experience database"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4023-9625","authenticated-orcid":false,"given":"Amy","family":"Lin","sequence":"first","affiliation":[{"name":"The Ohio State University College of Medicine Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arjun K.","family":"Menta","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Department of Otolaryngology\u2010Head and Neck Surgery Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Ameen","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Department of Otolaryngology\u2010Head and Neck Surgery Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aileen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Department of Otolaryngology\u2010Head and Neck Surgery Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dianela","family":"Perdomo","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Department of Otolaryngology\u2010Head and Neck Surgery Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-1169-3020","authenticated-orcid":false,"given":"Ashwin","family":"Reddy","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Department of Otolaryngology\u2010Head and Neck Surgery Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan K.","family":"Ward","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Department of Otolaryngology\u2010Head and Neck Surgery Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,6]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(20)30367\u20106"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.18280\/ria.360408"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0000000000000562"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10162\u2010022\u201000882\u2010y"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoto.2019.2274"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100038\u20101669411"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12913\u2010023\u201009900\u2010y"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.4427"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.28949"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/978\u2010981\u201019\u20100452\u20103"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/14670100.2023.2172828"},{"key":"e_1_2_8_13_1","unstructured":"HiRes Ultra 3D Cochlear Implant. Accessed April 8 2024https:\/\/www.advancedbionics.com\/us\/en\/home\/explore\/processors\u2010and\u2010cochlear\u2010implants\/hires\u2010ultra\u20103d\u2010and\u2010mri\u2010compatibility"},{"key":"e_1_2_8_14_1","unstructured":"Cochlear\u2122 Nucleus\u00ae Profile\u2122 Plus series implant. Accessed April 8 2024https:\/\/www.cochlear.com\/us\/en\/professionals\/products-and-candidacy\/nucleus\/implant\/nucleus-profile-plus"},{"key":"e_1_2_8_15_1","unstructured":"SYNCHRONY Cochlear Implant. Accessed April 7 2024https:\/\/www.medel.com\/hearing-solutions\/cochlear-implants\/synchrony"},{"key":"e_1_2_8_16_1","unstructured":"SYNCHRONY 2 Cochlear Implant. Accessed April 7 2024https:\/\/www.medel.com\/en-us\/hearing-solutions\/cochlear-implants\/synchrony2"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.joto.2018.11.001"},{"key":"e_1_2_8_18_1","unstructured":"About Manufacturer and User Facility Device Experience (MAUDE) Database.2024. 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