Bilateral Cochlear Implant Benefit in Young Children
This study is ongoing, but not recruiting participants.
Sponsor:
Advanced Bionics
Information provided by:
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT00424307
First received: January 17, 2007
Last updated: June 24, 2011
Last verified: June 2011
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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:
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, 2013