Bilateral Cochlear Implant Benefit in Young Children

Status unconfirmed · Phase 4

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT00424307

Run by

Advanced Bionics

People needed

60

Starts

2007-01-01

Expected to finish

2012-04-01

Last updated by the study team

2011-06-27

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Boys Town National Research Hospital — Omaha, Nebraska, United States
• New York University — New York, New York, United States
• Dallas Otolaryngology Associates — Dallas, Texas, United States
• Glenrose Rehab Hospital — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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