Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

Deafness Clinical Trial

Official title: Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

Status Withdrawn

Clinical Trial Summary

The primary objective to this study is to describe the auditory development and performance of young deaf children who receive bilateral implants during the first two years following device activation.

Clinical Trial Description

The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months. Acquisition of auditory milestones and speech recognition skills, which underpin the development of spoken language, will be assessed on a battery of outcome measures typically used to quantify implant benefits. In addition, global quality of life and communicative performance will be assessed by parental proxy. Performance will be tracked after 3, 6, 12, 18, and 24 months of device use. The study also will identify variables that may predict the degree of bilateral implant benefit in young children (e.g., age at implant, pre-implant hearing thresholds, communication mode, family socioeconomic status, post-implant aided thresholds, simultaneous vs. staged placement of devices). ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness

• NCT number: NCT00604474
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Withdrawn
• Phase: N/A
• Start date: October 2007
• Completion date: May 2010