Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
NCT ID: NCT03304106
Last Updated: 2020-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2017-10-19
2019-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Newly Implanted CI Recipients
Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients
Commercially available cochlear implant and AI system
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
Existing CI recipients
Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients
Commercially available cochlear implant and AI system
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
Interventions
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Commercially available cochlear implant and AI system
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
Eligibility Criteria
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Inclusion Criteria
* Age 12 and older
* Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
* Group 2: 3 months or greater combined experience with commercially available sound processors
* Fluent spoken English skills
Exclusion Criteria
* Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
* Unwillingness or inability of the subject to comply with all investigational requirements
* Use of an acoustic component in the implanted ear
* Less than 18 active electrodes
* Hybrid L Cochlear Implant
12 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Locations
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Rocky Mountain Ear Center
Englewood, Colorado, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Midwest Ear Institute
Kansas City, Missouri, United States
New York University
New York, New York, United States
Hearts for Hearing
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cochlear Hearing Center Houston
Houston, Texas, United States
Peak ENT Associates
Provo, Utah, United States
Countries
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References
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Zwolan TA, Presley R, Chenier L, Buck B. Investigation of an Outcomes-Driven, Computer-Assisted Approach to CI Fitting in Newly Implanted Patients. Ear Hear. 2021 May/Jun;42(3):558-564. doi: 10.1097/AUD.0000000000000957.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CAM 5417
Identifier Type: -
Identifier Source: org_study_id