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Bilateral Cochlear Implant Benefit in Young Children

Primary Purpose

Hearing Loss

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
HiResolution Bionic Ear System
Sponsored by
Advanced Bionics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's HEAR Center
  • House Ear Institute
  • University of California, San Francisco
  • Tampa Bay Hearing and Balance Center
  • The Children's Memorial Hospital
  • Carle Foundation Hospital
  • Massachusetts Eye and Ear Infirmary
  • Spectrum Health Hospital
  • Midwest Ear Institute
  • Washington University of St. Louis
  • Boys Town National Research Hospital
  • New York University
  • Dallas Otolaryngology Associates
  • Glenrose Rehab Hospital

Outcomes

Primary Outcome Measures

Assessment of Speech Perception Skills

Secondary Outcome Measures

Health-Related Quality of Life and Assessment of Communicative Performance

Full Information

First Posted
January 17, 2007
Last Updated
June 24, 2011
Sponsor
Advanced Bionics
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1. Study Identification

Unique Protocol Identification Number
NCT00424307
Brief Title
Bilateral Cochlear Implant Benefit in Young Children
Official Title
Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Advanced Bionics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
HiResolution Bionic Ear System
Primary Outcome Measure Information:
Title
Assessment of Speech Perception Skills
Time Frame
Various time points
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life and Assessment of Communicative Performance
Time Frame
Various time points

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Joe Osberger, Ph.D.
Organizational Affiliation
Advanced Bionics
Official's Role
Study Chair
Facility Information:
Facility Name
Children's HEAR Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
House Ear Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Tampa Bay Hearing and Balance Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
The Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Spectrum Health Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Midwest Ear Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University of St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Boys Town National Research Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Dallas Otolaryngology Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Glenrose Rehab Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada

12. IPD Sharing Statement

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Bilateral Cochlear Implant Benefit in Young Children

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