[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519114":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":72},{"fullName":5,"class":6},"Hospital Universitario La Paz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fittig with DSL-BCD","EXPERIMENTAL","The new way of fitting the audioprocessor",[13],"Procedure: Fitting of the audioprocessor with the auditory implant BCI602",{"label":15,"type":16,"description":17,"interventionNames":18},"Fitting with DSL v5","ACTIVE_COMPARATOR","The way of fitting the audioprocessor until now",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Fitting of the audioprocessor with the auditory implant BCI602","to compare the performance with BB system in two fitting-configurations (active comparator: DSL v5, experimental: DSL-BCD) using audiometric and subjective measures",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Javier Gavilan","Hospital La Paz","STUDY_CHAIR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+34917270000","javier.gavilan@salud.madrid.org",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":38},"Miryam Calvino","miryamcf@yahoo.com",[40],{"facility":5,"status":41,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Madrid","28046","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],-3.70256,40.4165,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":34,"phoneExt":25,"email":35},"Javier Gavilán",{"type":56,"investigatorFullName":37,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Investigator, Member of the Research Department",[59],{"name":60,"class":61},"MED-EL Elektromedizinische Geräte GesmbH","INDUSTRY","100519114","subjective-and-audiological-benefit-of-bonebridge-bci602-with-two-different-fitting-strategies-100519114",false,"NCT06039332","Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies","Inclusion Criteria:\n\n* 18 years of age or older\n* Unilateral and\u002For bilateral conductive or mixed hearing loss (CHL\u002FMHL) in indication range.\n* Implanted with a BCI602 device.\n* Willingness and ability to use the hearing system and to perform all tests required for the study\n* Signed, and dated informed consent before the start of any study specific procedure\n* Native speaker\n\nExclusion Criteria:\n\n* Profound unilateral sensorineural hearing loss, often termed Single sided deafness (SSD)\n* Retrocochlear, or central auditory disorders\n* Any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures\n* Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study.\n* Fluctuating hearing loss.",true,"ALL","18 Years",{"count":72,"type":73},1,"ESTIMATED","INTERVENTIONAL",[76],"NA","The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria).\n\nThe BB augments hearing by providing acoustic input to the inner ear via bone conduction.\n\nIn 2017 Hodgetts \\& Scollie introduced a new fitting algorithm called DSL-BCD. The DSL-BCD algorithm was developed especially for the characteristics of bone conduction devices (BCD). If there is a benefit on the patient level in hearing outcomes when comparing the application of DSL-BCD in comparison to DSL v5 when using the BB, was not yet investigated.\n\nThe aim of this clinical study is to show the improvement in audiological performance and subjective satisfaction with the BCI602 and SAMBA 2 audio processor in patients with conductive hearing loss compared to the unaided condition and to evaluate performance differences through application of 2 different fitting algorithms, namely DSL v5 and DSL-BCD.",[79,80,81],"Bone Conduction Deafness","Quality of Life","Hearing Loss, Mixed","2023-09-09",{"date":84,"type":85},"2023-09-15","ACTUAL",{"date":87,"type":85},"2023-06-27",{"date":89,"type":73},"2026-06-27",{"name":5,"class":6}]