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NCT00424307 Clinical Trial

Bilateral Cochlear Implant Benefit in Young Children

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00424307
Other study ID # ACR0906
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received January 17, 2007
Last updated June 24, 2011
Start date January 2007
Est. completion date April 2012

Study information
Verified date June 2011
Source Advanced Bionics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 36 Months
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• HiResolution Bionic Ear System

Locations
Country Name City State
Canada Glenrose Rehab Hospital Edmonton Alberta
United States Children's HEAR Center Birmingham Alabama
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts
United States The Children's Memorial Hospital Chicago Illinois
United States Dallas Otolaryngology Associates Dallas Texas
United States Spectrum Health Hospital Grand Rapids Michigan
United States Midwest Ear Institute Kansas City Missouri
United States House Ear Institute Los Angeles California
United States New York University New York New York
United States Boys Town National Research Hospital Omaha Nebraska
United States University of California, San Francisco San Francisco California
United States Washington University of St. Louis St. Louis Missouri
United States Tampa Bay Hearing and Balance Center Tampa Florida
United States Carle Foundation Hospital Urbana Illinois

Sponsors (1)
Lead Sponsor Collaborator
Advanced Bionics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of Speech Perception Skills Various time points No
Secondary Health-Related Quality of Life and Assessment of Communicative Performance Various time points No
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