{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T13:55:55Z","timestamp":1790430955054,"version":"4.1.0"},"reference-count":39,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2021,5,17]],"date-time":"2021-05-17T00:00:00Z","timestamp":1621209600000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008626","name":"Cochlear","doi-asserted-by":"publisher","award":["IIR1975"],"award-info":[{"award-number":["IIR1975"]}],"id":[{"id":"10.13039\/100008626","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,4,25]]},"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method and analysis<\/jats:title>\n                    <jats:p>\n                      In this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI)\n                      <jats:underline>&gt;<\/jats:underline>\n                      32, Beck\u2019s Depression Index &lt;19, pure tone average at 0.5, 1, 2 kHz: bilateral threshold between \u226540 and \u226480 dB and hearing thresholds in the ear to be implanted (\u22654 kHz) \u226550 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:bold>Trial registration number<\/jats:bold>\n                      NL8693; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-043288","type":"journal-article","created":{"date-parts":[[2021,5,18]],"date-time":"2021-05-18T11:50:57Z","timestamp":1621338657000},"page":"e043288","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Cochlear implantation for tinnitus in adults with bilateral hearing loss: protocol of a randomised controlled trial"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2667-9499","authenticated-orcid":false,"given":"Kelly","family":"Assouly","sequence":"first","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"Cochlear Technology Centre, Mechelen, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9126-9969","authenticated-orcid":false,"given":"Adriana L","family":"Smit","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5154-7178","authenticated-orcid":false,"given":"Inge","family":"Stegeman","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koenraad S","family":"Rhebergen","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bas","family":"van Dijk","sequence":"additional","affiliation":[{"name":"Cochlear Technology Centre, Mechelen, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8037-2573","authenticated-orcid":false,"given":"Robert","family":"Stokroos","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"University Medical Center Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,5,18]]},"reference":[{"key":"2025121601475216000_11.5.e043288.1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2017.00232"},{"key":"2025121601475216000_11.5.e043288.2","doi-asserted-by":"crossref","DOI":"10.1155\/2015\/608437","article-title":"Pathology of tinnitus and Hyperacusis-Clinical implications","volume":"2015","author":"Moller","year":"2015","journal-title":"Biomed Res Int"},{"key":"2025121601475216000_11.5.e043288.3","doi-asserted-by":"crossref","unstructured":"M\u00f8ller AR . 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