A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
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ClinicalTrials.gov Identifier: NCT02102256 |
Recruitment Status :
Active, not recruiting
First Posted : April 2, 2014
Last Update Posted : February 15, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Profound Bilateral Deafness Due to Bilateral Cochlear Aplasia Bilateral Cochlear Nerve Deficiency Bilateral Cochlear Ossification Secondary to Meningitis | Device: Auditory Brainstem Implant | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | January 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental
Device Implantation
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Device: Auditory Brainstem Implant
Other Name: Cochlear Corporation Nucleus 24 |
- Primary endpoint [ Time Frame: 12-months post-device activation ]Serious adverse event (count) per subject. Count of expected serious adverse events per subject.
- Secondary endpoint: Preliminary efficacy [ Time Frame: 3 years post-device activation ]Access to sound at a level (dB) and with the frequency range (500-4000Hz), known to be associated with speech.
- Unexpected Serious Adverse Events [ Time Frame: 12-months post-activation ]Unexpected adverse events (count).

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Ages Eligible for Study: | 2 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102256
United States, California | |
Keck School of Medicine of USC | |
Los Angeles, California, United States, 90008 | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States |
Principal Investigator: | Laurie S. Eisenberg, PhD | Keck School of Medicine of USC | |
Principal Investigator: | Eric Wilkinson, MD | Huntington Medical Research Institute |
Responsible Party: | Laurie Eisenberg, Professor of Research Otolaryngology, University of Southern California |
ClinicalTrials.gov Identifier: | NCT02102256 |
Other Study ID Numbers: |
KSOM-ABI 001 |
First Posted: | April 2, 2014 Key Record Dates |
Last Update Posted: | February 15, 2019 |
Last Verified: | February 2019 |
deafness congenital pediatric device |
Deafness Hearing Loss Meningitis Central Nervous System Diseases Nervous System Diseases |
Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations |