Status:
UNKNOWN
Bilateral Cochlear Implant Benefit in Young Children
Lead Sponsor:
Advanced Bionics
Conditions:
Hearing Loss
Eligibility:
All Genders
12-36 years
Phase:
PHASE4
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 i...
Eligibility Criteria
Inclusion
- 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
- Deafness secondary to meningitis
- Presence of other conditions that could affect study participation
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00424307
Start Date
January 1 2007
End Date
April 1 2012
Last Update
June 27 2011
Active Locations (14)
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1
Children's HEAR Center
Birmingham, Alabama, United States, 35233
2
House Ear Institute
Los Angeles, California, United States, 90057
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Tampa Bay Hearing and Balance Center
Tampa, Florida, United States, 33606