At a glance
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Iowa/Nucleus 10/10 mm and Nucleus Freedom Cochlear Implants Implanted Bilaterally in Children Ages 12-24 Months
In Brief
A clinical study evaluating Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation for Hearing Loss, Sensorineural and Hearing Loss, Bilateral. Completed, enrolled 9 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.