Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Primary Purpose
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Commercially available cochlear implant and AI system
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss, Bilateral
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
Sites / Locations
- Rocky Mountain Ear Center
- Greater Baltimore Medical Center
- University of Michigan
- Midwest Ear Institute
- New York University
- Hearts for Hearing
- Vanderbilt University Medical Center
- Cochlear Hearing Center Houston
- Peak ENT Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Newly Implanted CI Recipients
Existing CI recipients
Arm Description
Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients
Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03304106
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
September 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newly Implanted CI Recipients
Arm Type
Experimental
Arm Description
Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients
Arm Title
Existing CI recipients
Arm Type
Experimental
Arm Description
Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients
Intervention Type
Device
Intervention Name(s)
Commercially available cochlear implant and AI system
Intervention Description
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
Primary Outcome Measure Information:
Title
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
Description
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.
Time Frame
Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rocky Mountain Ear Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Midwest Ear Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Cochlear Hearing Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Peak ENT Associates
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33027199
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
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