Brief Title
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Official Title
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Brief Summary
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
Study Type
Interventional
Primary Outcome
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
Condition
Sensorineural Hearing Loss, Bilateral
Intervention
Commercially available cochlear implant and AI system
Study Arms / Comparison Groups
Newly Implanted CI Recipients
Description: Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
102
Start Date
October 19, 2017
Completion Date
September 18, 2019
Primary Completion Date
September 18, 2019
Eligibility Criteria
Inclusion Criteria: Newly implanted and existing recipient Groups (Groups 1 and 2): - 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: - Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations - 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
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03304106
Organization ID
CAM 5417
Responsible Party
Sponsor
Study Sponsor
Cochlear
Study Sponsor
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Verification Date
October 2020