MedPath

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

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
NameTimeMethod
Assessment of Speech Perception SkillsVarious time points
Secondary Outcome Measures
NameTimeMethod
Health-Related Quality of Life and Assessment of Communicative PerformanceVarious time points

Trial Locations

Locations (14)

Children's HEAR Center

🇺🇸

Birmingham, Alabama, United States

House Ear Institute

🇺🇸

Los Angeles, California, United States

University of California, San Francisco

🇺🇸

San Francisco, California, United States

Tampa Bay Hearing and Balance Center

🇺🇸

Tampa, Florida, United States

The Children's Memorial Hospital

🇺🇸

Chicago, Illinois, United States

Carle Foundation Hospital

🇺🇸

Urbana, Illinois, United States

Massachusetts Eye and Ear Infirmary

🇺🇸

Boston, Massachusetts, United States

Spectrum Health Hospital

🇺🇸

Grand Rapids, Michigan, United States

Midwest Ear Institute

🇺🇸

Kansas City, Missouri, United States

Washington University of St. Louis

🇺🇸

St. Louis, Missouri, United States

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

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