protocolSection identificationModule nctId: NCT06293482, orgStudyIdInfo id: CAM5850, briefTitle: Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population, acronym: ACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cochlear, class: INDUSTRY, collaborators name: NAMSA, collaborators name: LWB Consulting, descriptionModule 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., conditionsModule conditions: Hearing Loss, Sensorineural, conditions: Hearing Loss, Bilateral, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cochlear™ Nucleus® System, outcomesModule primaryOutcomes measure: Number of device and procedure-related adverse events and serious adverse events, primaryOutcomes 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, primaryOutcomes 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, secondaryOutcomes measure: Number of device and procedure related adverse events and serious adverse events, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes measure: Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition, secondaryOutcomes measure: Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barrow Neurological Institute, city: Phoenix, state: Arizona, zip: 85013, country: United States, contacts name: Shawn Stevens, role: CONTACT, email: shawn.stevens@commonspirit.org, geoPoint lat: 33.44838, lon: -112.07404, locations facility: University of Miami, city: Coral Gables, state: Florida, zip: 33146, country: United States, contacts name: Meredith Holcomb, role: CONTACT, email: meredith.holcomb@med.miami.edu, geoPoint lat: 25.72149, lon: -80.26838, locations facility: Midwest Ear Institute, city: Kansas City, state: Missouri, zip: 64111, country: United States, contacts name: Sarah Zlomke, role: CONTACT, email: sking@saint-lukes.org, geoPoint lat: 39.09973, lon: -94.57857, locations facility: New York University, city: New York, state: New York, zip: 10016, country: United States, contacts name: William Shapiro, role: CONTACT, email: william.shapiro@nyulangone.org, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Sarah Sydlowski, role: CONTACT, email: sydlows@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, locations facility: University of Pennsylvania Hospitals, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Tiffany Hwa, role: CONTACT, email: tiffany.hwa@pennmedicine.upenn.edu, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23219, country: United States, contacts name: Daniel Coelho, role: CONTACT, email: daniel.coelho@vcuhealth.org, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Virginia Mason, city: Seattle, state: Washington, zip: 98101, country: United States, contacts name: Daniel Zeitler, role: CONTACT, email: daniel.zeitler@virginiamason.org, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False