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Auditory Brainstem Implant for Bilateral Hearing Loss

Q: How many people have enrolled in this clinical trial?

Affirmative. According to the information on clinicaltrials.gov, enrollment for this trial began in May of 2014 and is still ongoing with a most recent update posted in May of 2022. The study requires 20 volunteers from just one medical institution.

Q: Is this experiment presently enrolling participants?

Affirmative. Clinicaltrials.gov's records demonstrate that this research project, which was first made visible on May 1st 2014, is accepting applicants presently. The team behind the trial needs to enrol 20 participants from a single site.

Q: Does this clinical research extend eligibility to elderly individuals?

Patients that wish to join this clinical trial must range between 18 months and 21 years of age. Separately, there are 53 trials for those below the legal consenting age and 129 studies involving participants over the pensionable age.

Q: What criteria must be met for a person to become part of this clinical trial?

This clinical trial seeks 20 individuals between 18 months and 21 years of age who suffer from bilateral <a href="https://www.withpower.com/clinical-trials/hearing-loss">hearing loss</a> not caused by tumors. Applicants must meet several criteria, including severe inner ear malformation, post-meningitis ossification, lack of progress in auditory skills development, group 2: post-linguistic hearing loss (under the age of 21), when a cochlea is present or patent with no significant benefit from CI despite consistent use (over 6 months) and limited to no speech perception ability on closed set testing materials using CI.

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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,578 Total Patients Enrolled

John T. Roland, Jr., MDPrincipal InvestigatorNYU Langone Health

Media Library

Nucleus ABI541 Auditory Brainstem Implant (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02310399 — N/A

Bilateral Hearing Loss Research Study Groups: Pre-lingual Deafness, Post-Lingual Deafness

Bilateral Hearing Loss Clinical Trial 2023: Nucleus ABI541 Auditory Brainstem Implant Highlights & Side Effects. Trial Name: NCT02310399 — N/A

Nucleus ABI541 Auditory Brainstem Implant (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02310399 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have enrolled in this clinical trial?

"Affirmative. According to the information on clinicaltrials.gov, enrollment for this trial began in May of 2014 and is still ongoing with a most recent update posted in May of 2022. The study requires 20 volunteers from just one medical institution."

Answered by AI

Is this experiment presently enrolling participants?

"Affirmative. Clinicaltrials.gov's records demonstrate that this research project, which was first made visible on May 1st 2014, is accepting applicants presently. The team behind the trial needs to enrol 20 participants from a single site."

Answered by AI

Does this clinical research extend eligibility to elderly individuals?

"Patients that wish to join this clinical trial must range between 18 months and 21 years of age. Separately, there are 53 trials for those below the legal consenting age and 129 studies involving participants over the pensionable age."

Answered by AI

What criteria must be met for a person to become part of this clinical trial?

"This clinical trial seeks 20 individuals between 18 months and 21 years of age who suffer from bilateral hearing loss not caused by tumors. Applicants must meet several criteria, including severe inner ear malformation, post-meningitis ossification, lack of progress in auditory skills development, group 2: post-linguistic hearing loss (under the age of 21), when a cochlea is present or patent with no significant benefit from CI despite consistent use (over 6 months) and limited to no speech perception ability on closed set testing materials using CI."

Answered by AI