Status:
COMPLETED
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Lead Sponsor:
Cochlear
Conditions:
Sensorineural Hearing Loss, Bilateral
Cochlear Implant
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03304106
Start Date
October 19 2017
End Date
September 18 2019
Last Update
October 29 2020
Active Locations (9)
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1
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
2
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
3
University of Michigan
Ann Arbor, Michigan, United States, 48108
4
Midwest Ear Institute
Kansas City, Missouri, United States, 64111