An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
NCT ID: NCT03904420
Last Updated: 2020-10-29
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
4 participants
INTERVENTIONAL
2019-02-26
2019-10-29
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
OTHER
NONE
Study Groups
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Group A - New Model
Standardized programming and testing method
Clinical Education and Treatment Model
Patients will have self directed equipment education and standardized programming approaches
Group B - Traditional Model
Traditional clinical model which is not standardized across clinical sites
Traditional Model
Standard clinical practice and education
Interventions
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Clinical Education and Treatment Model
Patients will have self directed equipment education and standardized programming approaches
Traditional Model
Standard clinical practice and education
Eligibility Criteria
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Inclusion Criteria
* 18 years and older
* Postlingual onset of hearing loss (onset of hearing loss \>two years of age)
* Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
* Individuals who have recently been implanted but not yet had their external device activated
* Willingness to participate in a study and comply with all study requirements
* Fluent in spoken English
Exclusion Criteria
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Subject considering an acoustic component in the implanted ear
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
* Unwillingness or inability to comply with all investigational requirements
* Severe-profound sensorineural hearing loss \>30 years
* Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator
18 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Locations
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Head and Neck Surgical Associates
Wichita Falls, Texas, United States
Puget Sound ENT
Edmonds, Washington, 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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CAM5753
Identifier Type: -
Identifier Source: org_study_id