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NCT03304106 Clinical Trial

Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Cochlear Implant Clinical Trial

Official title:
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03304106
Other study ID # CAM 5417
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2017
Est. completion date September 18, 2019

Study information
Verified date October 2020
Source Cochlear
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date September 18, 2019
Est. primary completion date September 18, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Commercially available cochlear implant and AI system
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Greater Baltimore Medical Center Baltimore Maryland
United States Rocky Mountain Ear Center Englewood Colorado
United States Cochlear Hearing Center Houston Houston Texas
United States Midwest Ear Institute Kansas City Missouri
United States Vanderbilt University Medical Center Nashville Tennessee
United States New York University New York New York
United States Hearts for Hearing Oklahoma City Oklahoma
United States Peak ENT Associates Provo Utah

Sponsors (1)
Lead Sponsor Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Monosyllabic Word Recognition Scores (CNC) in Quiet Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use. Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month
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