Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
NYU Langone Health
Summary
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.
Description
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 ag…
Eligibility
- Age range
- 1–21 years
- Sex
- All
- Healthy volunteers
- No
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 mat…
Interventions
- DeviceNucleus ABI541 Auditory Brainstem Implant
Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device
Location
- NYU Cochlear Implant CenterNew York, New York