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A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients

NCT02102256 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-15

Study results available
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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

  • Profound Bilateral Deafness Due to
  • Bilateral Cochlear Aplasia
  • Bilateral Cochlear Nerve Deficiency
  • Bilateral Cochlear Ossification Secondary to Meningitis

Interventions

DEVICE

Auditory Brainstem Implant

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • Children's Hospital Los Angeles

    collaborator OTHER

  • Huntington Medical Research Institutes

    collaborator OTHER

  • Laurie Eisenberg

    lead OTHER

Principal Investigators

  • Laurie S. Eisenberg, PhD · Keck School of Medicine of USC

  • Eric Wilkinson, MD · Huntington Medical Research Institute

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2021-04-06
Completion
2021-04-06

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 NCT02102256 on ClinicalTrials.gov