Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
1 other identifier
interventional
102
1 country
9
Brief Summary
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2017
CompletedFirst Posted
Study publicly available on registry
October 6, 2017
CompletedStudy Start
First participant enrolled
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2019
CompletedResults Posted
Study results publicly available
October 29, 2020
CompletedOctober 29, 2020
October 1, 2020
1.9 years
October 3, 2017
September 9, 2020
October 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Newly Implanted CI Recipients
EXPERIMENTALUse of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients
Existing CI recipients
EXPERIMENTALUse of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients
Interventions
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (9)
Rocky Mountain Ear Center
Englewood, Colorado, 80113, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
University of Michigan
Ann Arbor, Michigan, 48108, United States
Midwest Ear Institute
Kansas City, Missouri, 64111, United States
New York University
New York, New York, 10016, United States
Hearts for Hearing
Oklahoma City, Oklahoma, 73120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Cochlear Hearing Center Houston
Houston, Texas, 77074, United States
Peak ENT Associates
Provo, Utah, 84604, United States
Related Publications (1)
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.
PMID: 33027199DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Chenier, Clinical Project Manager
- Organization
- Cochlear Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2017
First Posted
October 6, 2017
Study Start
October 19, 2017
Primary Completion
September 18, 2019
Study Completion
September 18, 2019
Last Updated
October 29, 2020
Results First Posted
October 29, 2020
Record last verified: 2020-10