Bilateral Cochlear Implant Benefit in Young Children

NCT ID: NCT00424307

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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HiResolution Bionic Ear System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Bionics

INDUSTRY

Sponsor Role lead

Responsible Party

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Advanced Bionics, LLC

Principal Investigators

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Mary Joe Osberger, Ph.D.

Role: STUDY_CHAIR

Advanced Bionics

Locations

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Children's HEAR Center

Birmingham, Alabama, United States

Site Status

House Ear Institute

Los Angeles, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Tampa Bay Hearing and Balance Center

Tampa, Florida, United States

Site Status

The Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Spectrum Health Hospital

Grand Rapids, Michigan, United States

Site Status

Midwest Ear Institute

Kansas City, Missouri, United States

Site Status

Washington University of St. Louis

St Louis, Missouri, United States

Site Status

Boys Town National Research Hospital

Omaha, Nebraska, United States

Site Status

New York University

New York, New York, United States

Site Status

Dallas Otolaryngology Associates

Dallas, Texas, United States

Site Status

Glenrose Rehab Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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ACR0906

Identifier Type: -

Identifier Source: org_study_id

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