{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T04:15:35Z","timestamp":1784693735830,"version":"3.55.0"},"reference-count":17,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,4,13]],"date-time":"2017-04-13T00:00:00Z","timestamp":1492041600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:sec><jats:title>Objectives\/Hypothesis<\/jats:title><jats:p>1) To provide long\u2010term hearing outcome measures of a totally implantable hearing system (implant) and compare to the baseline unaided (BLU) and baseline aided (BLA) conditions, and 2) discuss relevant safety measures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design<\/jats:title><jats:p>Prospective, nonrandomized, multicenter, single\u2010subject\u2010as\u2010own\u2010control design.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Fifty\u2010one subjects with mild to severe sensorineural hearing loss were implanted between 2008 and 2009 and enrolled in this postmarket approval study in the setting of private and hospital\u2010based practices. Forty\u2010nine of these subjects completed the 5\u2010year study, which included annual follow\u2010ups. Primary effectiveness endpoints were speech reception threshold (SRT) and word recognition scores at 50 dB (WRS50s). Secondary effectiveness endpoints were WRSs and the Abbreviated Profile of Hearing Aid Benefit (APHAB) scores. Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) reported during the study period and a comparison of bone conduction scores are submitted as safety measures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Compared to the BLA condition, 1) SRT scores were improved at every annual follow\u2010up; 2) WRS50s were better in 49%, and the same in 41% at the 5\u2010year follow\u2010up; 3) WRSs were improved by 17% at the 5\u2010year follow\u2010up; and 4) APHAB scores were improved in most subscales at every annual follow\u2010up. There were three SADEs in three subjects and 15 ADEs in 11 subjects. Bone conduction scores increased by 3.7 dB at the 5\u2010year follow\u2010up. Average battery life was 4.9 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The implant compared favorably to the subjects' hearing aid throughout the 5\u2010year period in all of the areas measured and was found to be safe.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>2b. <jats:italic>Laryngoscope<\/jats:italic>, 128:210\u2013216, 2018<\/jats:p><\/jats:sec>","DOI":"10.1002\/lary.26602","type":"journal-article","created":{"date-parts":[[2017,4,13]],"date-time":"2017-04-13T18:37:04Z","timestamp":1492108624000},"page":"210-216","source":"Crossref","is-referenced-by-count":17,"title":["Totally implantable hearing system: Five\u2010year hearing results"],"prefix":"10.1002","volume":"128","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7599-3033","authenticated-orcid":false,"given":"Jack A.","family":"Shohet","sequence":"first","affiliation":[{"name":"Shohet Ear Associates Newport Beach California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric M.","family":"Kraus","sequence":"additional","affiliation":[{"name":"Ear Center of Greensboro Greensboro North Carolina U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter J.","family":"Catalano","sequence":"additional","affiliation":[{"name":"St. Elizabeth's Medical Center Boston Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Toh","sequence":"additional","affiliation":[{"name":"Lahey Hospital &amp; Medical Center Boston Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,4,13]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"16","article-title":"An introduction to MarkeTrak IX\u2014a new baseline for the hearing aid market","volume":"22","author":"Abrams H","year":"2015","journal-title":"Hear Rev"},{"key":"e_1_2_7_3_1","first-page":"59","article-title":"The Esteem system: a totally implantable hearing device","volume":"69","author":"Maurer J","year":"2010","journal-title":"Adv Otorhinolaryngol"},{"key":"e_1_2_7_4_1","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1001\/archotol.1974.00780040415023","article-title":"Speech induced cochlear potentials","volume":"100","author":"Mahoney T","year":"1974","journal-title":"Arch Otolaryngol"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mlg.0000147938.52132.4b"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599811401709"},{"key":"e_1_2_7_7_1","doi-asserted-by":"crossref","first-page":"815","DOI":"10.1007\/978-3-642-23499-6_939","volume-title":"Encyclopedia of Otolaryngology, Head and Neck Surgery","author":"Shohet JA","year":"2013"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1044\/jshr.2103.507"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003446-199504000-00005"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599812458401"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0b013e3182382bc8"},{"key":"e_1_2_7_12_1","doi-asserted-by":"crossref","first-page":"2027","DOI":"10.1007\/s00405-012-2252-8","article-title":"Esteem\u00ae middle ear device versus conventional hearing aids for rehabilitation of bilateral sensorineural hearing loss","volume":"270","author":"Monini S","year":"2013","journal-title":"Eur Arch Otorhinolaryngol"},{"key":"e_1_2_7_13_1","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1159\/000338689","article-title":"Esteem 2 middle ear implant: our experience","volume":"17","author":"Gerard JM","year":"2012","journal-title":"Audiol Neurootol"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0000000000001015"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-014-3276-z"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00405-016-4361-2"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.25872"},{"key":"e_1_2_7_18_1","first-page":"1","article-title":"Light\u2010driven contact hearing aid for broad\u2010spectrum amplification: Safety and effectiveness pivotal study","volume":"37","author":"Gantz BJ","year":"2016","journal-title":"Otol Neurotol"}],"container-title":["The Laryngoscope"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Flary.26602","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lary.26602","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,29]],"date-time":"2023-09-29T20:04:00Z","timestamp":1696017840000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lary.26602"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,4,13]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,1]]}},"alternative-id":["10.1002\/lary.26602"],"URL":"https:\/\/doi.org\/10.1002\/lary.26602","archive":["Portico"],"relation":{},"ISSN":["0023-852X","1531-4995"],"issn-type":[{"value":"0023-852X","type":"print"},{"value":"1531-4995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,4,13]]}}}