Bilateral Cochlear Implant Benefit in Young Children
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
1 other identifier
interventional
60
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2007
Longer than P75 for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 27, 2011
June 1, 2011
5.3 years
January 17, 2007
June 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of Speech Perception Skills
Various time points
Secondary Outcomes (1)
Health-Related Quality of Life and Assessment of Communicative Performance
Various time points
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Deafness secondary to meningitis
- Presence of other conditions that could affect study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Bionicslead
Study Sites (14)
Children's HEAR Center
Birmingham, Alabama, 35233, United States
House Ear Institute
Los Angeles, California, 90057, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Tampa Bay Hearing and Balance Center
Tampa, Florida, 33606, United States
The Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
Spectrum Health Hospital
Grand Rapids, Michigan, 49546, United States
Midwest Ear Institute
Kansas City, Missouri, 64111, United States
Washington University of St. Louis
St Louis, Missouri, 63110, United States
Boys Town National Research Hospital
Omaha, Nebraska, 68131, United States
New York University
New York, New York, 10016, United States
Dallas Otolaryngology Associates
Dallas, Texas, 75230, United States
Glenrose Rehab Hospital
Edmonton, Alberta, T6G 2C8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mary Joe Osberger, Ph.D.
Advanced Bionics
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 19, 2007
Study Start
January 1, 2007
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
June 27, 2011
Record last verified: 2011-06