MedTrace Logo

Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study

NCT00594061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-05-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral

Interventions

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.

Sponsors & Collaborators

  • Bruce J Gantz

    lead OTHER

Principal Investigators

  • Bruce J Gantz, MD · University of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594061 on ClinicalTrials.gov