Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves

Recruiting now · Not applicable

Conditions studied: Hearing Loss, Bilateral (Causes Other Than Tumors)

In brief

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.

Key facts

Study ID: NCT02310399
Run by: NYU Langone Health
People needed: 20
Starts: 2014-05-01
Expected to finish: 2030-05-01
Last updated by the study team: 2025-10-30

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Group 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years)
Pre-linguistic hearing loss (birth-5 yrs.; age at ABI 18 months-5yrs) with both:
MRI +/- CT evidence of one of the following:
Cochlear nerve deficiency
Cochlear aplasia or severe hypoplasia
Severe inner ear malformation
Post-meningitis ossification
When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (>6 mo.)
No or limited speech perception ability (limited to pattern perception on closed set testing materials using the CI)
Lack of progress in auditory skills development
Group 2: Post-linguistic hearing loss (<21 yrs. of age)
Post-linguistic hearing loss (<21 yrs. of age) with:
Loss or lack of benefit from appropriate CI without the possibility for revision or contralateral implantation. Examples might include:
Post-meningitis ossification
Bilateral temporal bone fractures with cochlear nerve avulsion
Failed revision CI without benefit
Previously developed open set speech perception and auditory-oral language skills
No medical contraindications
Willing to receive the appropriate meningitis vaccinations
No or limited cognitive/developmental delays.
Strong family support
Reasonable expectations from parents/guardians including a thorough understanding:
of potential benefits and limitations of ABI
of parental role in rehabilitation
that the child may not develop spoken language as a primary communication mode or even sufficient spoken language to make significant academic progress in an aural/oral environment

You may not qualify if…

For both Groups 1 and 2:
Pre- or post-linguistic child currently making significant progress with CI Even for the very young children (18 months of age with 6 months of use), nearly all children with a good auditory signal from their CI will show evidence of improvement in these metrics over time.
MRI evidence of one of the following:
normal cochlea and cochlear nerves or NF2
brainstem or cortical anomaly that makes implantation unfeasible
Clear surgical reason for poor CI performance that can be remediated with revision CI or contralateral surgery rather than ABI.
Intractable seizures or progressive, deteriorating neurological disorder
Patients with evidence of Chiari malformation, hydrocephalus, spina bifid a
Patients with any foreseeable need for a future MRI scan
Unable to participate in behavioral testing and mapping with their CI. If this appears to be an age effect, ABI will be delayed until we can be assured that the child will be able to participate, as reliable objective measures of mapping are currently not available for mapping these devices.
Unable to tolerate general anesthesia (cardiac, pulmonary, bleeding diathesis, etc.).
Need for brainstem irradiation
Unrealistic expectations on the part of the subject/family regarding the possible benefits, risks and limitations inherent to the procedure and ABI device.
Unwilling to sign the informed consent.
Unwilling to make necessary follow-up appointments.

Where it is running

NYU Cochlear Implant Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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