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Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

NCT03156465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-01-08

Study results available
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Summary

The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 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. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

Conditions

  • Implants, Cochlear
  • Child
  • Hearing Loss, Bilateral

Interventions

DEVICE

Hybrid L24

Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Bruce J Gantz, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-15
Primary Completion
2022-11-03
Completion
2022-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03156465 on ClinicalTrials.gov