What side effects are associated with this type of intervention?

The most common treatments for bilateral hearing loss, such as cochlear implants and auditory brainstem implants (ABIs), can have several side effects. For ABIs, which involve direct electrical stimulation of the brainstem, potential side effects include dizziness, facial nerve stimulation, cerebrospinal fluid leakage, and infection at the implant site. Cochlear implants, which are more common, can also cause dizziness, tinnitus, and surgical risks such as infection and device failure. Both treatments aim to provide auditory input but come with these associated risks.

What prior FDA approvals exist?

The FDA has approved the Nucleus 24 Auditory Brainstem Implant (ABI) for patients with Neurofibromatosis type 2 (NF2) who have bilateral hearing loss and are not candidates for cochlear implants. This device directly stimulates the brainstem to provide auditory input, bypassing the damaged auditory nerves. Other treatments for bilateral hearing loss include cochlear implants, which are also FDA-approved and work by directly stimulating the cochlea to restore hearing. These treatments are crucial for individuals who cannot benefit from traditional hearing aids due to severe or profound hearing loss.

What other types of research exist?

Promising novel alternatives to the Nucleus 24 ABI for bilateral hearing loss patients include: 1) Advanced cochlear implants, such as the Nucleus 22 channel intracochlear implant, which has shown success in patients with good nerve function. 2) Transcutaneous supraorbital nerve stimulation, which has demonstrated benefits in reducing migraine days and could potentially be adapted for auditory stimulation. 3) Single-pulse transcranial magnetic stimulation (sTMS), which has shown promise in reducing headache days and may offer a non-invasive option for auditory input. These alternatives leverage different mechanisms to provide auditory input and may offer new hope for patients with bilateral hearing loss.

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Device

Auditory Brainstem Implant for Bilateral Hearing Loss

Q: What is the mechanism of action of this treatment?

The Nucleus 24 Auditory Brainstem Implant (ABI) directly stimulates the brainstem to provide auditory input, bypassing the damaged or absent cochlea and auditory nerve. This is essential for Bilateral Hearing Loss patients who cannot benefit from traditional hearing aids or cochlear implants due to the absence or malfunction of the auditory nerve. Other treatments, like cochlear implants, stimulate the auditory nerve to send signals to the brain but require a functional auditory nerve. Understanding these mechanisms helps in selecting the appropriate treatment based on the specific nature of the hearing loss.

N/A

Recruiting

Led By John T. Roland, Jr., MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-meningitis ossification

Group 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years) with MRI +/- CT evidence of cochlear nerve deficiency, cochlear aplasia or severe hypoplasia, severe inner ear malformation, or post-meningitis ossification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years from date of surgery

Awards & highlights

Study Summary

This trial will test how well the Nucleus 24 ABI works in children without NF2. Results will be compared to those with normal hearing and with CIs.

Who is the study for?

This trial is for children with severe to profound hearing loss who have no cochleae or auditory nerves. It includes those aged 18 months-5 years born with hearing loss and those under 21 who lost hearing later but can't benefit from cochlear implants due to specific inner ear issues, ossification after meningitis, or other damage. Participants need strong family support and must be able to travel for the study.Check my eligibility

What is being tested?

The Nucleus ABI541 Auditory Brainstem Implant (ABI) is being tested in children without neurofibromatosis type 2 (NF2). The study measures how well the implant works over time by comparing it to normal hearing and traditional cochlear implants. This research will help design future studies on ABIs in kids.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include risks associated with surgery such as infection, anesthesia complications, device malfunction, and limited improvement in hearing which could affect speech development.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have bone growth after meningitis.

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My child was born with hearing loss and has inner ear issues confirmed by MRI or CT.

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I have very limited or no ability to understand speech and haven't improved with hearing aids.

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I lost my hearing after learning to speak and can't benefit from a cochlear implant due to specific medical reasons.

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I received a hearing implant between 18 months and 5 years old due to early hearing loss.

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I have fractures in both sides of my skull affecting my hearing nerve.

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I have an underdeveloped or missing inner ear structure.

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I lost my hearing after learning to speak and I am under 21.

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I have a problem with the nerve that connects my ear to my brain.

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I have a severe inner ear deformity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years from date of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years from date of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from date of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ABI Device Complications

Secondary outcome measures

Audiologic Performance with ABI (Hearing, Speech and Language Assessments)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pre-lingual DeafnessExperimental Treatment1 Intervention

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

Group II: Post-Lingual DeafnessExperimental Treatment1 Intervention

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Nucleus 24 Auditory Brainstem Implant (ABI) directly stimulates the brainstem to provide auditory input, bypassing the damaged or absent cochlea and auditory nerve. This is essential for Bilateral Hearing Loss patients who cannot benefit from traditional hearing aids or cochlear implants due to the absence or malfunction of the auditory nerve. Other treatments, like cochlear implants, stimulate the auditory nerve to send signals to the brain but require a functional auditory nerve. Understanding these mechanisms helps in selecting the appropriate treatment based on the specific nature of the hearing loss.

The effect of upper pontine transections on normal cochlear responses and on the protective effects of contralateral acoustic stimulation in barbiturate-anaesthetized normal-hearing guinea pigs.