Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2019-03-27
2020-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A (Immediate Cochlear Implantation)
Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation.
Cochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant
Group B (Delayed Cochlear Implantation)
Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation.
Cochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant
Interventions
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Cochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant
Eligibility Criteria
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Inclusion Criteria
* Proficient in English
* Oral communicator
* PTA (500, 1000 \& 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years
* Active daily hearing aid users
* HHIE-S score greater than or equal to 24
* MoCA score greater than or equal to 20
* Post-linguistic onset sensorineural hearing loss and meet applicable FDA and/or Medicare candidacy criteria for cochlear implantation
* Willing to consent for the study, to be randomized to either group, to utilize bimodal hearing for the duration of the trial (if clinically appropriate), and follow the study protocol
Exclusion Criteria
* Previous cochlear implantation in either ear
* Hearing loss of neural or central origin
* Permanent conductive hearing impairment (e.g. otosclerosis)
* Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation
* Self reported disability in 2 or more activities of daily living
* Vision impairment worse than 20/40 on a near vision card
65 Years
85 Years
ALL
No
Sponsors
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CogState Ltd.
INDUSTRY
Syneos Health
OTHER
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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David N Cade, MD, MBA
Role: STUDY_DIRECTOR
Cochlear
Locations
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Arizona Center for Neurosciences
Tucson, Arizona, United States
House Ear Institute
Los Angeles, California, United States
Washington University
St Louis, Missouri, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati Health
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLTD5693
Identifier Type: -
Identifier Source: org_study_id