Actively Recruiting
Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
Led by NYU Langone Health · Updated on 2025-10-30
20
Participants Needed
1
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prelinguistic hearing loss with implantation age between 18 months and 5 years
- MRI or CT evidence of cochlear nerve deficiency, cochlear aplasia, severe inner ear malformation, or post-meningitis ossification
- When cochlea is present, lack of significant benefit from cochlear implant after more than 6 months of use with limited speech perception and auditory skill progress
- Post-linguistic hearing loss in children under 21 years with loss or lack of benefit from cochlear implant and no option for revision or contralateral implantation
- Previously developed open set speech perception and auditory-oral language skills
- No medical contraindications to surgery
- Willingness to receive meningitis vaccinations
- No or limited cognitive or developmental delays
- Strong family support and reasonable expectations about ABI benefits and limitations
- Participation in auditory skill rehabilitation programs
- Ability to comply with study requirements including travel
- Informed consent provided by parent or legal guardian
You will not qualify if you...
- Significant progress with cochlear implant at time of screening
- MRI evidence of normal cochlea and cochlear nerves or diagnosis of NF2
- Brainstem or cortical anomalies that prevent implantation
- Clear surgical reasons for poor cochlear implant performance that can be addressed without ABI
- Intractable seizures or progressive neurological disorders
- Chiari malformation, hydrocephalus, spina bifida
- Need for future MRI scans
- Inability to participate in behavioral testing and device mapping
- Inability to tolerate general anesthesia due to medical conditions
- Need for brainstem irradiation
- Unrealistic expectations about the ABI procedure and device
- Unwillingness to sign informed consent or follow up with study appointments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Cochlear Implant Center
New York, New York, United States, 10016
Actively Recruiting
Research Team
W
William Shapiro
CONTACT
A
Ashley Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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