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Feasibility Study of Auditory Brainstem Implant in Young Children

NCT01850225 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-03-18

No results posted yet for this study

Summary

Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.

Conditions

  • Bilateral Cochlear Aplasia
  • Bilateral Cochlear Nerve Deficiency
  • Bilateral Cochlear Ossification Secondary to Meningitis

Interventions

DEVICE

Auditory brainstem implant

Sponsors & Collaborators

Principal Investigators

  • Eric Wilkinson, MD · House Research Institute

  • Laurie Eisenberg, PhD · House Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01850225 on ClinicalTrials.gov