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

NCT02102256 | Completed Phase 1 Results DMC

• 1 other identifier: KSOM-ABI 001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

deafness; congenital; pediatric; device

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Surgical Safety The number of subjects successfully implanted.

  12-months post-device (auditory brainstem implant) successful activation

Secondary Outcomes (1)

• Secondary Endpoint: Preliminary Efficacy

  3 years post-device activation

Study Arms (1)

Experimental

EXPERIMENTAL

Device Implantation

Device: Auditory Brainstem Implant

Interventions

Auditory Brainstem Implant DEVICE

Also known as: Cochlear Corporation Nucleus 24

Experimental

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Medical contraindication to craniotomy/intracranial surgery
• Severe cognitive or developmental delays

Sponsors & Collaborators

• Laurie Eisenberg: lead
• University of Southern California: collaborator
• Children's Hospital Los Angeles: collaborator
• Huntington Medical Research Institutes: collaborator

Study Sites (2)

Keck School of Medicine of USC

Los Angeles, California, 90008, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (4)

• Fisher LM, Eisenberg LS, Krieger M, Wilkinson EP, Shannon RV; Los Angeles Pediatric ABI Team. Regulatory and funding strategies to develop a safety study of an auditory brainstem implant in young children who are deaf. Ther Innov Regul Sci. 2015 Sep;49(5):659-665. doi: 10.1177/2168479015599559. No abstract available.

  PMID: 26366332 RESULT

• Wilkinson EP, Eisenberg LS, Krieger MD, Schwartz MS, Winter M, Glater JL, Martinez AS, Fisher LM, Shannon RV; Los Angeles Pediatric ABI Team. Initial Results of a Safety and Feasibility Study of Auditory Brainstem Implantation in Congenitally Deaf Children. Otol Neurotol. 2017 Feb;38(2):212-220. doi: 10.1097/MAO.0000000000001287.

  PMID: 27898605 RESULT

• Fisher LM, Martinez AS, Richmond FJ, Krieger MD, Wilkinson EP, Eisenberg LS. Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses. Ther Innov Regul Sci. 2018 Sep;52(5):669-679. doi: 10.1177/2168479017741111. Epub 2017 Nov 29.

  PMID: 29714549 RESULT

• Eisenberg LS, Hammes Ganguly D, Martinez AS, Fisher LM, Winter ME, Glater JL, Schrader DK, Loggins J, Wilkinson EP; Los Angeles Pediatric ABI Team. Early Communication Development of Children with Auditory Brainstem Implants. J Deaf Stud Deaf Educ. 2018 Jul 1;23(3):249-260. doi: 10.1093/deafed/eny010.

  PMID: 29718280 RESULT

MeSH Terms

Conditions

Deafness

Interventions

Auditory Brain Stem Implants

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Results Point of Contact

• Title: Dr. Laurie Eisenberg
• Organization: University of Southern California

laurie.eisenberg@med.usc.edu

213-764-2826

Study Officials

• Laurie S. Eisenberg, PhD

  Keck School of Medicine of USC

  PRINCIPAL INVESTIGATOR

• Eric Wilkinson, MD

  Huntington Medical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Research Otolaryngology

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)