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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00594061 |
The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss and meet the criteria for cochlear implantation. The Iowa/Nucleus 10/10 mm cochlear implant has a short, 10 mm electrode array that it is inserted only into the more basal region of the cochlea. Unlike a conventional cochlear implant, the Iowa/Nucleus 10/10 mm is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. The Iowa/Nucleus 10/10 mm will be implanted in the contralateral ear from the Nucleus Freedom electrode array as a means of providing bilateral stimulation of auditory pathways while preserving the middle and apical regions of the scala media.
Condition | Intervention |
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Hearing Loss, Sensorineural Hearing Loss, Bilateral |
Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Iowa/Nucleus 10/10 mm and Nucleus Freedom Cochlear Implants Implanted Bilaterally in Children Ages 12-24 Months |
Estimated Enrollment: | 10 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.
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Ages Eligible for Study: | 12 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Bruce J Gantz, MD | University of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program |
Responsible Party: | Univeristy of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program ( Bruce J. Gantz, MD ) |
Study ID Numbers: | IA/NU G070130-S001, NIDCD P50 DC00242 |
Study First Received: | January 3, 2008 |
Last Updated: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00594061 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases Sensorineural hearing loss |
Hearing Loss, Bilateral Neurologic Manifestations Hearing Loss, Sensorineural Hearing Loss Ear Diseases |
Nervous System Diseases |