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Auditory Brainstem Implantation in Young Children

NCT01904448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-07-05

Study results available
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Summary

To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or cochlear nerve disorders. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or cochlear malformation.

This study proposes to implant up to 10 young children (\<5 yrs. of age) with the Nucleus 24 Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure, tolerance of device stimulation, and the potential for auditory benefit beyond that experienced with their CI. This study will provide the preliminary experience for a larger scale clinical trial.

Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development of sound awareness and improved speech understanding among children implanted with the ABI when compared to their baseline skills. Aim 3: Demonstrate the development of oral language skills following the use of the ABI that were not evident prior to its use.

Conditions

  • Developmental Cochlear Nerve Deficiency
  • Acquired Cochlear Nerve Deficiency
  • Cochlear Aplasia
  • Post-meningitis Cochlear Ossification
  • Cochlear Malformation

Interventions

DEVICE

Auditory Brainstem Implantation in Children

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Craig A Buchman, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-10-01
Completion
2017-10-01

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 NCT01904448 on ClinicalTrials.gov