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Bilateral Cochlear Implant Benefit in Young Children
This study is ongoing, but not recruiting participants.

First Received on January 17, 2007.   Last Updated on June 24, 2011   History of Changes
Sponsor: Advanced Bionics
Information provided by: Advanced Bionics
ClinicalTrials.gov Identifier: NCT00424307
  Purpose

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 Intervention Phase
Hearing Loss
 Device: HiResolution Bionic Ear System
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness
MedlinePlus related topics: Hearing Disorders and Deafness
U.S. FDA Resources

Further study details as provided by Advanced Bionics:

Primary Outcome Measures:
  • Assessment of Speech Perception Skills [ Time Frame: Various time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-Related Quality of Life and Assessment of Communicative Performance [ Time Frame: Various time points ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: HiResolution Bionic Ear System
    .
    Other Name: HiResolution Bionic Ear System
  Eligibility

Ages Eligible for Study:   12 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424307

Locations
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
Investigators
Study Chair: Mary Joe Osberger, Ph.D. Advanced Bionics
  More Information

No publications provided

Responsible Party: Kenneth Ripley, Advanced Bionics, LLC
ClinicalTrials.gov Identifier: NCT00424307     History of Changes
Other Study ID Numbers: ACR0906
Study First Received: January 17, 2007
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2012



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