[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466935":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":70,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":31,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":31,"enrollmentInfo":87,"targetDuration":31,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":31,"overallStatus":56,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard fitting","PLACEBO_COMPARATOR","The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9",[13],"Procedure: Standard Fitting",{"label":15,"type":16,"description":17,"interventionNames":18},"Anatomy-based fitting","EXPERIMENTAL","In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9",[19],"Procedure: Anatomy-based fitting (ABF)",{"label":21,"type":16,"description":22,"interventionNames":23},"Within-subject design: Standard fitting + ABF","The third group constitutes the within-subject design. These subjects are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting.",[24],"Procedure: Standard fitting+ ABF",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Anatomy-based fitting (ABF)","MAESTRO 9 can display the tonotopic frequency of each individual electrode channel imported from OTOPLAN to further support fitting based on these measures. The audiologist can set a frequency-band distribution that is more closely aligned to the tonotopic frequency distribution as imported from OTOPLAN.",[15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Standard Fitting","These group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9.",[9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Standard fitting+ ABF","Patients of this group are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.",[21],[41],{"name":42,"affiliation":5,"role":43},"Luis Lassaletta, PhD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":31,"email":48},"CONTACT","0034656898265","llasaletta@salud.madrid.org",{"name":50,"role":46,"phone":51,"phoneExt":31,"email":52},"Miryam Calvino, PhD","0034646354267","miryamcf@yahoo.com",[54],{"facility":55,"status":56,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Hospital Universitario de La Paz","RECRUITING","Madrid","28046","Spain","ES",{"type":62,"coordinates":63},"Point",[64,65],-3.70256,40.4165,{"lat":65,"lon":64},[68],{"name":69,"role":46,"phone":31,"phoneExt":31,"email":52},"Miryam Calvino",{"type":43,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Luis Lassaletta","Doctor",[74],{"name":75,"class":76},"MED-EL Elektromedizinische Geräte GesmbH","INDUSTRY","100466935","anatomy-based-fitting-in-cochear-implant-users-100466935",false,"NCT05360212","Anatomy-based Fitting in Cochear Implant Users","Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)\n* Post-OP CT scan of the CI electrode available\n* Subject implanted with MED-EL cochlear implant(s)\n* Subjects received a Flex28 or FlexSoft electrode\n* Subject planned to receive a SONNET 2 \u002FRONDO3 audio processor on the newly implanted side\n* Audio processor not yet activated on the newly implanted side\n* The most apical active electrode contact has to be inserted at least 450°\n* Minimum of 10 active channels can be activated\n* Fluent in Spanish\n* Signed and dated ICF before the start of any study-specific procedure\n\nSpecific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2\u002FRONDO3 audio processor on the first ear implanted\n\n* 40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side\n* 40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion\n\n  • Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)\n\n  • SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB\n\n  • Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB\n\nExclusion Criteria:\n\n* Lack of compliance with any inclusion criteria\n* EAS user (user of an EAS audio processor)\n* Implanted with C40+, C40X and C40C\n* Implanted with an ABI or Split electrode array\n* Known allergic reactions to components of the investigational medical device\n* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study",true,"ALL","18 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"NA","In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.",[95,96,97],"Cochlear Implant","Outcomes","Quality of Life","2025-08-06",{"date":100,"type":101},"2025-08-12","ACTUAL",{"date":103,"type":101},"2022-03-11",{"date":105,"type":89},"2026-12-31",{"name":5,"class":6},1]