Bilateral Cochlear Implant Benefit in Young Children

June 24, 2011 updated by: Advanced Bionics

Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of Speech Perception Skills
Time Frame: Various time points
Various time points

Secondary Outcome Measures

Outcome Measure
Time Frame
Health-Related Quality of Life and Assessment of Communicative Performance
Time Frame: Various time points
Various time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Bionics

Investigators

  • Study Chair: Mary Joe Osberger, Ph.D., Advanced Bionics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 18, 2007

First Posted (Estimate)

January 19, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACR0906

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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