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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2030-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects

NCT01736267

Bilateral Hearing Loss for Causes Other Than Tumors

TERMINATED NA

Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

NCT05810220

Deafness

RECRUITING NA

Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

NCT03156465

Implants, Cochlear Child Hearing Loss, Bilateral

COMPLETED NA

Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

NCT00678899

Sensorineural Hearing Loss

COMPLETED NA

Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook

NCT04041596

Cochlear Implant Cochlear Hearing Loss

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to evaluate the clinical safety and efficacy of the Nucleus™ 24 Auditory Brainstem Implant (ABI) in pediatric patients who do not have Neurofibromatosis Type 2 (NF2); specifically, children with total hearing loss due to severe cochlear anomalies, cochlear nerve disorders or failed cochlear implantation. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia, post-meningitis cochlear ossification, or cochlear malformation. This study proposes to implant up to 10 pre-linguistic young children (18 mos to 5 yrs. of age) and up to 10 post-linguistic children (\<21 yrs of age) with the Nucleus 24 Multichannel ABI in an attempt to demonstrate safety of the surgical procedure and device stimulation and the potential for auditory benefit beyond that experienced with a CI. These children would not qualify for the Nucleus ABI device, as their etiology is not an approved indication such as neurofibromatosis Type 2(NF2). Further, these children do not benefit from conventional hearing aids or cochlear implants.

Two groups of children will be included: Group 1 will include prelingiustic deaf children ages 18 months - 5 years and Group 2 will include postlinguistic deaf children \< 21 years of age. Post-operative evaluations will be conducted at the initial activation and at 1, 3, 6, 12, 18, 24, 30, and 36-month intervals post-activation in order to demonstrate the emergence of open-set speech perception abilities prior to study cessation. Experience in the CI literature has shown that a minimum of 2 years of device usage is required for children with pre-lingual hearing impairment to develop some open-set speech perception abilities. While Group 2 is post-linguistic and some may have had significant hearing prior to becoming deaf, the same time intervals will be used for consistency. Blinding or masking procedures are not included in the design, as the presence/absence of a brainstem implant cannot be easily concealed from the device recipients and/or clinical investigators.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Bilateral (Causes Other Than Tumors)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-lingual Deafness

Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in prelingiustically deaf children ages 18 months - 5 years

Group Type EXPERIMENTAL

Nucleus ABI541 Auditory Brainstem Implant

Intervention Type DEVICE

Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device

Post-Lingual Deafness

Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in postlinguistically deaf children \< 21 years of age

Group Type EXPERIMENTAL

Nucleus ABI541 Auditory Brainstem Implant

Intervention Type DEVICE

Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nucleus ABI541 Auditory Brainstem Implant

Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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
* 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 Criteria

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.

Minimum Eligible Age

18 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No