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Clinical Trial Summary

This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.


Clinical Trial Description

Unilateral hearing loss (UHL) is a term used to describe a substantial hearing loss in one ear and normal hearing in the contralateral ear. Despite normal hearing in one ear, these individuals experience reduced speech perception in noise, variable abilities on localization tasks, increased reports of hearing handicap, reduced quality of life, and often, they obtain limited or no benefit from conventional amplification. In the United States, the prevalence of UHL in children ranges from 0.03% to 3%, depending on the age of the child. Cochlear implantation performed for children with bilateral, severe to profound deafness has significant impacts on several aspects of child development. The practice of providing cochlear implants to children who have significant hearing loss in one ear is of great interest and is occurring with greater frequency as reported in case studies and small set clinical reports. The primary purpose of this feasibility study is to demonstrate the effectiveness of cochlear implantation in children, age 3 years 6 months to 6 years, 6 months, with moderate to profound UHL. Postoperative results will be evaluated with speech perception measures, localization tasks, hearing in noise tasks, and subjective reports. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02963974
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase N/A
Start date April 20, 2017
Completion date May 7, 2021

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