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Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves

NCT02310399 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-30

No results posted yet for this study

Summary

This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results. Data obtained in the course of this study will be compared with the existing published outcome data from children with normal hearing and with cochlear implants (CIs). These comparisons may provide additional useful information about the progress of ABI subjects' performance over time. Also, this may allow the results of the current study to be utilized to design future pivotal studies of the device in the pediatric population.

Conditions

  • Hearing Loss, Bilateral (Causes Other Than Tumors)

Interventions

DEVICE

Nucleus ABI541 Auditory Brainstem Implant

Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device

Sponsors & Collaborators

Principal Investigators

  • John T. Roland, Jr., MD · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2030-05-31
Completion
2030-05-31
FDA Device
Yes

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 NCT02310399 on ClinicalTrials.gov