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Sponsored by: |
Med-El Corporation |
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Information provided by: | Med-El Corporation |
ClinicalTrials.gov Identifier: | NCT00784043 |
The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.
Condition | Intervention |
---|---|
Hearing Loss |
Device: Cochlear Implant |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems. |
Estimated Enrollment: | 60 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Audiological:
Medical:
Exclusion Criteria:
Medical:
United States, Florida | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32207 | |
United States, Georgia | |
Children's Healthcare of Atlanta | |
Atlanta, Georgia, United States, 30324 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44124 | |
United States, Texas | |
Callier Center | |
Dallas, Texas, United States, 75235 | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
Dallas Otolaryngology Associates | |
Dallas, Texas, United States, 75230 | |
United States, Virginia | |
Eastern Virginia Medical School | |
Norfolk, Virginia, United States, 23507 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Canada, Ontario | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 5A5 |
Responsible Party: | MED-EL Corporation ( Richard Collette, CEO ) |
Study ID Numbers: | MED-EL NA 013 |
Study First Received: | October 30, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00784043 |
Health Authority: | United States: Institutional Review Board |
Cochlear implant hearing loss |
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness |
Otorhinolaryngologic Diseases Neurologic Manifestations Hearing Loss Ear Diseases |
Nervous System Diseases |