Working... Menu

Bilateral Cochlear Implant Benefit in Young Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00424307
Recruitment Status : Unknown
Verified June 2011 by Advanced Bionics.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2007
Last Update Posted : June 27, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: HiResolution Bionic Ear System Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
Study Start Date : January 2007
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Assessment of Speech Perception Skills [ Time Frame: Various time points ]

Secondary Outcome Measures :
  1. Health-Related Quality of Life and Assessment of Communicative Performance [ Time Frame: Various time points ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424307

Layout table for location information
United States, Alabama
Children's HEAR Center
Birmingham, Alabama, United States, 35233
United States, California
House Ear Institute
Los Angeles, California, United States, 90057
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
Tampa Bay Hearing and Balance Center
Tampa, Florida, United States, 33606
United States, Illinois
The Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
United States, Michigan
Spectrum Health Hospital
Grand Rapids, Michigan, United States, 49546
United States, Missouri
Midwest Ear Institute
Kansas City, Missouri, United States, 64111
Washington University of St. Louis
St. Louis, Missouri, United States, 63110
United States, Nebraska
Boys Town National Research Hospital
Omaha, Nebraska, United States, 68131
United States, New York
New York University
New York, New York, United States, 10016
United States, Texas
Dallas Otolaryngology Associates
Dallas, Texas, United States, 75230
Canada, Alberta
Glenrose Rehab Hospital
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
Advanced Bionics
Layout table for investigator information
Study Chair: Mary Joe Osberger, Ph.D. Advanced Bionics

Layout table for additonal information
Responsible Party: Kenneth Ripley, Advanced Bionics, LLC Identifier: NCT00424307     History of Changes
Other Study ID Numbers: ACR0906
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms