{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T18:31:14Z","timestamp":1740162674809,"version":"3.37.3"},"reference-count":23,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T00:00:00Z","timestamp":1687219200000},"content-version":"unspecified","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Cochlear Research and Development Limited","award":["IIR-2185"],"award-info":[{"award-number":["IIR-2185"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>In the new revised National Institute for Health &amp; Care Excellence (NICE, TA566, 2019) guidelines for cochlear implantation (CI) have clearly stipulated that the hearing loss must be bilateral. Prior to this revision, children and young people (CYP) with asymmetrical thresholds have been considered for unilateral CI when one ear was in audiological criteria. Children with asymmetrical hearing loss represent an important cohort of potential CI candidates, who will continue to be prevented from benefiting from CI unless evidence is produced to support implantation and maximise subsequent benefit.<\/jats:p><jats:p>The aim of this study is to evaluate the \u2018real-life\u2019 hearing performance in a group of children who have received a unilateral CI and who have hearing thresholds in the contralateral ear that are outside the current UK NICE 2019 audiological criteria for CI. The contralateral ear will be aided using a conventional hearing aid (HA). The outcomes from this \u2018bimodal\u2019 group will be compared with a group of children who have received bilateral CI, and a group of children using bilateral HA, to extend the current knowledge about the different performance levels between bilateral CI, bilateral HA and bimodal hearing in CYP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>Thirty CYP aged 6\u201317 years old, 10 bimodal users, 10 bilateral HA users and 10 bilateral cochlear implant users will be subjected to a test battery consisting of: (1) spatial release from masking, (2) complex pitch direction discrimination, (3) melodic identification, (4) perception of prosodic features in speech and (5) TEN test. Subjects will be tested in their optimal device modality. Standard demographic and hearing health information will be collected. In the absence of comparable published data to power the study, sample size was determined on pragmatic grounds. Tests are exploratory and for hypothesis generating purposes. Therefore, the standard criterion of p&lt;0.05\u2009will be used.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>This has been approved by the Health Research Authority and NHS REC within the UK (22\/EM\/0104). Industry funding was secured via a competitive researcher-led grant application process. Trial results will be subject to publication according to the definition of the outcome presented in this protocol.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2022-071168","type":"journal-article","created":{"date-parts":[[2023,6,20]],"date-time":"2023-06-20T17:16:25Z","timestamp":1687281385000},"page":"e071168","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Children using a unilateral cochlear implant and contralateral hearing aid: bimodal hearing outcomes when one ear is outside the UK (NICE 2009) audiological criteria for cochlear implantation \u2013 a single site case\u2013control study"],"prefix":"10.1136","volume":"13","author":[{"given":"Iain","family":"Bruce","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simone","family":"Schaefer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3638-2787","authenticated-orcid":false,"given":"Karolina","family":"Kluk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaya","family":"Nichani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Odriscoll","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Azita","family":"Rajai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9269-9474","authenticated-orcid":false,"given":"Mark","family":"Sladen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,6,20]]},"reference":[{"key":"2023073121214582000_13.6.e071168.1","unstructured":"NICE . Cochlear implants for children and adults with severe to profound Deafness. NICE technology appraisal guidance. 2009. Available: http:\/\/www.nice.org.uk\/ta166"},{"key":"2023073121214582000_13.6.e071168.2","unstructured":"Cochlear implants for children and adults with severe to profound Deafness. NICE technology appraisal guidance. 2019. Available: http:\/\/www.nice.org.uk\/ta566"},{"key":"2023073121214582000_13.6.e071168.3","doi-asserted-by":"publisher","DOI":"10.3310\/hta20220"},{"key":"2023073121214582000_13.6.e071168.4","doi-asserted-by":"publisher","DOI":"10.1044\/2015_JSLHR-H-14-0075"},{"issue":"Suppl 1","key":"2023073121214582000_13.6.e071168.5","doi-asserted-by":"crossref","first-page":"S78","DOI":"10.1080\/14992020600782956","article-title":"Benefits of bilateral Cochlear implants and\/or hearing aids in children","volume":"45 Suppl 1","author":"Litovsky","year":"2006","journal-title":"Int J Audiol"},{"key":"2023073121214582000_13.6.e071168.6","doi-asserted-by":"publisher","DOI":"10.3766\/jaaa.18.9.5"},{"key":"2023073121214582000_13.6.e071168.7","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1179\/cim.2009.10.Supplement-1.23","article-title":"Bimodal fitting or bilateral implantation","volume":"10","author":"Ching","year":"2009","journal-title":"Cochlear Implants International"},{"key":"2023073121214582000_13.6.e071168.8","doi-asserted-by":"crossref","first-page":"3620","DOI":"10.1044\/2019_JSLHR-H-18-0255","article-title":"Effects of early acoustic hearing on speech perception and language for pediatric Cochlear implant recipients","volume":"62","author":"Davidson","year":"2019","journal-title":"J Speech Lang Hear Res"},{"key":"2023073121214582000_13.6.e071168.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2009.01.009"},{"key":"2023073121214582000_13.6.e071168.10","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1080\/14670100.2016.1155832","article-title":"Unilateral Cochlear implantation in children with a potentially useable contralateral ear","volume":"17","author":"Sadadcharam","year":"2016","journal-title":"Cochlear Implants International"},{"key":"2023073121214582000_13.6.e071168.11","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1044\/2016_AJA-16-0051","article-title":"Considerations for pediatric Cochlear implant recipients with unilateral or asymmetric hearing loss: assessment, device fitting, and Habilitation","volume":"26","author":"Greaver","year":"2017","journal-title":"Am J Audiol"},{"key":"2023073121214582000_13.6.e071168.12","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1080\/14670100.2018.1536408","article-title":"Improved speech and language development after unilateral Cochlear implantation in children with a potentially useable contralateral ear","volume":"20","author":"Schaefer","year":"2019","journal-title":"Cochlear Implants International"},{"key":"2023073121214582000_13.6.e071168.13","doi-asserted-by":"publisher","DOI":"10.1177\/1084713807304357"},{"key":"2023073121214582000_13.6.e071168.14","doi-asserted-by":"publisher","DOI":"10.1080\/14992020500190003"},{"key":"2023073121214582000_13.6.e071168.15","doi-asserted-by":"publisher","DOI":"10.1159\/000218361"},{"key":"2023073121214582000_13.6.e071168.16","doi-asserted-by":"crossref","unstructured":"Bruce I , Schaefer S , Kluk K , et al . Benefit of hearing preservation Cochlear implantation in the Paediatric population: a single-site case\u2013control study. BMJ Open 2023;13:e067248. doi:10.1136\/bmjopen-2022-067248","DOI":"10.1136\/bmjopen-2022-067248"},{"key":"2023073121214582000_13.6.e071168.17","doi-asserted-by":"publisher","DOI":"10.1121\/1.3523295"},{"key":"2023073121214582000_13.6.e071168.18","doi-asserted-by":"publisher","DOI":"10.3109\/03005369409086564"},{"key":"2023073121214582000_13.6.e071168.19","doi-asserted-by":"publisher","DOI":"10.1097\/AUD.0b013e3181a61bc0"},{"key":"2023073121214582000_13.6.e071168.20","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1097\/AUD.0b013e3181c34ccb","article-title":"Diagnosing Cochlear dead regions in children","volume":"31","author":"Malicka","year":"2010","journal-title":"Ear Hear"},{"key":"2023073121214582000_13.6.e071168.21","doi-asserted-by":"crossref","first-page":"385","DOI":"10.1007\/s40136-020-00314-6","article-title":"Bilateral Cochlear implants or Bimodal hearing for children with bilateral Sensorineural hearing loss","volume":"8","author":"Gifford","year":"2020","journal-title":"Curr Otorhinolaryngol Rep"},{"key":"2023073121214582000_13.6.e071168.22","doi-asserted-by":"crossref","first-page":"4030","DOI":"10.1044\/2021_JSLHR-20-00720","article-title":"Bimodal fitting and bilateral Cochlear implants in children with significant residual hearing: the impact of asymmetry in spatial release of masking on localization","volume":"64","author":"Sparreboom","year":"2021","journal-title":"J Speech Lang Hear Res"},{"key":"2023073121214582000_13.6.e071168.23","doi-asserted-by":"crossref","unstructured":"Crew JD , Galvin III JJ , Landsberger DM , et al . Contributions of electric and acoustic hearing to Bimodal speech and music perception. PLoS ONE 2015;10:e0120279. doi:10.1371\/journal.pone.0120279","DOI":"10.1371\/journal.pone.0120279"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2022-071168","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,1]],"date-time":"2023-08-01T04:46:43Z","timestamp":1690865203000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2022-071168"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6]]},"references-count":23,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2023,6,20]]},"published-print":{"date-parts":[[2023,6]]}},"alternative-id":["10.1136\/bmjopen-2022-071168"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2022-071168","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2023,6]]}}}