A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
NCT ID: NCT02102256
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2014-03-31
2021-04-06
Brief Summary
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Detailed Description
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The Primary Aim is to describe the safety aspects of device implant surgery and 12-month use of an ABI in 10 pediatric patients (ages 2-6 years) with profound bilateral hearing loss not amenable to other treatments, such as hearing aids or cochlear implants. Surgical safety analysis is defined as no greater number of serious surgery-related adverse events than is commonly observed in non-NF2 adults undergoing craniotomy with or without an ABI and no more than four unexpected serious device-related adverse events for the 10 subjects during 12 months of follow-up. A Secondary Aim will determine whether or not the device provides patients with access to sound (thresholds of 50 dB HL) during a critical period for communication skills development. Efficacy is here defined as access to sound at a level and within the frequency range, known to be associated with speech.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Experimental
Device Implantation
Auditory Brainstem Implant
Interventions
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Auditory Brainstem Implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If previously received a cochlear implant, must demonstrate lack of benefit from that device
Exclusion Criteria
* Severe cognitive or developmental delays
2 Years
6 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Children's Hospital Los Angeles
OTHER
Huntington Medical Research Institutes
OTHER
Laurie Eisenberg
OTHER
Responsible Party
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Laurie Eisenberg
Professor of Research Otolaryngology
Principal Investigators
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Laurie S. Eisenberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Keck School of Medicine of USC
Eric Wilkinson, MD
Role: PRINCIPAL_INVESTIGATOR
Huntington Medical Research Institute
Locations
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Keck School of Medicine of USC
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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KSOM-ABI 001
Identifier Type: -
Identifier Source: org_study_id
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