nctId: NCT06293482 id: CAM5850 briefTitle: Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population acronym: ACE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2028-06 date: 2024-03-05 date: 2024-03-05 name: Cochlear class: INDUSTRY name: NAMSA name: LWB Consulting briefSummary: This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits. conditions: Hearing Loss, Sensorineural conditions: Hearing Loss, Bilateral studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Cochlear™ Nucleus® System measure: Number of device and procedure-related adverse events and serious adverse events measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted measure: Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition measure: Number of device and procedure related adverse events and serious adverse events measure: Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline measure: Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement measure: Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted measure: Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition measure: Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition measure: Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barrow Neurological Institute city: Phoenix state: Arizona zip: 85013 country: United States name: Shawn Stevens role: CONTACT email: shawn.stevens@commonspirit.org lat: 33.44838 lon: -112.07404 facility: University of Miami city: Coral Gables state: Florida zip: 33146 country: United States name: Meredith Holcomb role: CONTACT email: meredith.holcomb@med.miami.edu lat: 25.72149 lon: -80.26838 facility: Midwest Ear Institute city: Kansas City state: Missouri zip: 64111 country: United States name: Sarah Zlomke role: CONTACT email: sking@saint-lukes.org lat: 39.09973 lon: -94.57857 facility: New York University city: New York state: New York zip: 10016 country: United States name: William Shapiro role: CONTACT email: william.shapiro@nyulangone.org lat: 40.71427 lon: -74.00597 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Sarah Sydlowski role: CONTACT email: sydlows@ccf.org lat: 41.4995 lon: -81.69541 facility: University of Pennsylvania Hospitals city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Tiffany Hwa role: CONTACT email: tiffany.hwa@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23219 country: United States name: Daniel Coelho role: CONTACT email: daniel.coelho@vcuhealth.org lat: 37.55376 lon: -77.46026 facility: Virginia Mason city: Seattle state: Washington zip: 98101 country: United States name: Daniel Zeitler role: CONTACT email: daniel.zeitler@virginiamason.org lat: 47.60621 lon: -122.33207 hasResults: False