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| Sponsor: | Advanced Bionics |
|---|---|
| Information provided by: | Advanced Bionics |
| ClinicalTrials.gov Identifier: | NCT00424307 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
Eligibility| Ages Eligible for Study: | 12 Months to 36 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Andrew Quick | 877-526-9175 | aquick@advancedbionics.com |
| United States, Alabama | |
| Children's HEAR Center | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| House Ear Institute | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Contact: CARE Center 213-353-7005 | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact 415-353-2464 | |
| United States, Florida | |
| Tampa Bay Hearing and Balance Center | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact 813-844-4900 | |
| United States, Illinois | |
| Carle Foundation Hospital | Recruiting |
| Urbana, Illinois, United States, 61801 | |
| The Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact 773-880-4605 | |
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Spectrum Health Hospital | Recruiting |
| Grand Rapids, Michigan, United States, 49546 | |
| Contact 616-391-2862 | |
| United States, Missouri | |
| Midwest Ear Institute | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact 816-932-1660 | |
| Washington University of St. Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Boys Town National Research Hospital | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| United States, New York | |
| New York University | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: William Shapiro 212-263-7037 | |
| Principal Investigator: William Shapiro | |
| United States, Texas | |
| Dallas Otolaryngology Associates | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact 972-566-7600 | |
| Canada, Alberta | |
| Glenrose Rehab Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2C8 | |
| Contact (780) 735-6016 | |
| Study Chair: | Mary Joe Osberger, Ph.D. | Advanced Bionics |
More Information
| Responsible Party: | Advanced Bionics ( Andrew Quick ) |
| Study ID Numbers: | ACR0906 |
| Study First Received: | January 17, 2007 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00424307 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases |
Nervous System Diseases Neurologic Manifestations Hearing Loss Ear Diseases |
