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



Status:Active, not recruiting
Conditions:Other Indications, Other Indications, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:2 - 6
Updated:2/17/2019
Start Date:March 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients

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.


Inclusion Criteria:

- Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or
ossification secondary to meningitis

- If previously received a cochlear implant, must demonstrate lack of benefit from that
device

Exclusion Criteria:

- Medical contraindication to craniotomy/intracranial surgery

- Severe cognitive or developmental delays
We found this trial at
2
sites
Keck School of Medicine of USC
Los Angeles, California 90008
Principal Investigator: Laurie Eisenberg, PhD
Phone: 213-764-2807
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Childrens Hospital Los Angeles
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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