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Auditory Brainstem Implant (ABI) for Children with Severe Hearing Loss

This study is looking at the safety and effectiveness of the Nucleus ABI541 Auditory Brainstem Implant in children and young adults (ages 18 months to 21 years) who have severe hearing loss and cannot benefit from regular hearing aids or cochlear implants. This includes conditions like missing or underdeveloped cochlear nerves, severe inner ear problems, or hearing loss after meningitis. The study aims to see if this implant can help these children hear better. Researchers will compare the results to children with normal hearing and those with cochlear implants to learn more about how the ABI helps over time. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 20 participants. It is designed as a repeated-measures, single-subject experiment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for ABI Device Complications for 5 years from the date of surgery.

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NCT02310399

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

Recruiting
NAAges 18–21InterventionalTreatment
NYU Langone Health
~20 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Nucleus ABI541 Auditory Brainstem Implant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ABI Device Complications
Measured over 5 Years from date of surgery

Conditions

Hearing Loss, Bilateral (Causes Other Than Tumors)

Explore related trials

Hearing Loss

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • John T. Roland, Jr., MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

William Shapiro
[email protected]
212-263-3311
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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
Involvement in a rehabilitation program that emphasizes development of auditory skills with or without the use of supplementary visual communication.
Able to comply with study requirements including travel to investigation sites.
Informed consent for the procedure from the child's parents/legal guardian.

Exclusion

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.

What this trial measures

  • ABI Device Complications5 Years from date of surgery

    Study participants will be monitored on a case-by-case basis for ongoing or unanticipated medical complications. Adverse events will be tracked on a case-by-case basis and recorded at the time of occurrence and followed up at resolution. Any adverse events will be reported to the NYUSOM IRB. Should there be concern for the safety of the subjects because of their participation in the study by the investigators or the IRB, the study would be halted at least temporarily and a detailed discussion with the investigators and the IRB would be undertaken.