Bilateral Cochlear Implant Benefit in Young Children

Phase 4

• Conditions: Hearing Loss

• Registration Number: NCT00424307
• Lead Sponsor: Advanced Bionics

Brief Summary

The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-17
• Study First Submitted QC: 2007-01-18
• Study First Posted: 2007-01-19
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-27
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Profound bilateral hearing loss
• Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System
• Age at implant: 12-36 months
• No previous cochlear implant use
• English as the primary language spoken in the home
• Parental willingness to follow study protocol

Exclusion Criteria

• Deafness secondary to meningitis
• Presence of other conditions that could affect study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of Speech Perception Skills	Various time points

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life and Assessment of Communicative Performance	Various time points

Trial Locations

Locations (14)

House Ear Institute; 🇺🇸 Los Angeles, California, United States

Washington University of St. Louis; 🇺🇸 St. Louis, Missouri, United States

Dallas Otolaryngology Associates; 🇺🇸 Dallas, Texas, United States

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Children's HEAR Center; 🇺🇸 Birmingham, Alabama, United States

Carle Foundation Hospital; 🇺🇸 Urbana, Illinois, United States

The Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Spectrum Health Hospital; 🇺🇸 Grand Rapids, Michigan, United States

Midwest Ear Institute; 🇺🇸 Kansas City, Missouri, United States

New York University; 🇺🇸 New York, New York, United States

Boys Town National Research Hospital; 🇺🇸 Omaha, Nebraska, United States

Tampa Bay Hearing and Balance Center; 🇺🇸 Tampa, Florida, United States

Glenrose Rehab Hospital; 🇨🇦 Edmonton, Alberta, Canada