Clinical Trial: Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Iowa/Nucleus 10/10 mm and Nucleus Freedom Cochlear Implants Implanted Bilaterally in Children Ages 12-24 Months

Brief 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.

Detailed Summary:

The study will be conducted as a repeated-measure , single-subject experiment. A single- subject research design (in which each participant serves as his or her own control) is appropriate because it accommodates the heterogeneity that characterizes hearing- impaired population s. Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Preoperatively , candidates will be assessed with their current amplification to evaluate their appropriateness for entrance into the study. The candidates' audiometric configuration must meet the above inclusion criteria. That is, the candidate must have a severe-to-profound sensorineural hearing loss from 250 to 8000 Hz. Prior to testing, the appropriateness of the hearing aid fitting will be assessed and adjustments made if necessary. In cases where amplification has not been used for more than one year, new hearing aids will be fit, worn for a minimum three-month trial and the participants re- evaluated to confirm continuance with the study.

Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/ 10 mm electrode array on the contralateral side. Half will be implanted with the 10 mm electrode array on their right side and half will be implanted with the 10 mm electrode array on their left side. We will alternate every other subject between the right and left ears. Postoperatively, Iowa/Nucleus 10110 mm electrode alone, standard Freedom electrode alone, and bilateral listening (i.e., Iowa/Nucleus 10/ 10 mm and standard electrodes together) modes will be compared with repeated testing through five years of age of the child. These comparisons will help to evaluate the effects of bilateral stimulation using different
Sponsor: Bruce J Gantz

Current Primary Outcome: Speech Language Development [ Time Frame: Assessed longitudinally at 4, 8, and 12 months and annually thereafter ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Speech Perception Development [ Time Frame: Assessed longitudinally at 4, 8, and 12 months and annually thereafter ]

Original Secondary Outcome: Same as current

Information By: University of Iowa

Dates:
Date Received: January 3, 2008
Date Started: December 2007
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017