Study of the Nucleus 24 Auditory Brainstem Implant in Pediatric Non-Neurofibromatosis Type 2
The goal of this MEEI Auditory Brainstem Implant (ABI) research study is to find new ways to
improve hearing in children who are deaf and cannot receive a cochlear implant. The ABI is
a surgically placed bionic implant that converts sounds into electrical signals that are
directly transmitted to the cochlear nucleus, the first auditory center of the brain. For
many years, ABIs have improved the hearing of patients who are deaf due to brain tumors
associated with a genetic syndrome called Neurofibromatosis Type 2 (NF2). However, a number
of recent studies suggest that deaf patients who do not have NF2 and are not eligible for a
cochlear implant may also benefit from placement of an ABI. These preliminary studies
suggest that these non-NF2 or "nontumor" patients may actually have better outcomes after
ABI surgery than patients suffering from NF2. Children appear to be particularly good
candidates because of their developmental plasticity and in many studies, outcomes are more
favorable in children that adults. Patients who do not have NF2 and are deaf due to
abnormalities in their hearing nerves or inner ears from congenital malformations,
infection, disease, or injury are not cochlear implant candidates and there are no other
options to improve hearing in these cases except for the ABI. Thus, the purpose of our study
is to carefully analyze whether ABI surgery improves the hearing and quality of life of
non-NF2 children based on subjective and objective measures of their hearing before and
after ABI surgery. In particular, we plan to study ABI outcomes in non-NF2 pediatric
patients, characterize the parameters used on their devices, and determine the safety
profile of ABIs in these patients.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ABI Complications
We will track any major and minor complications peri-operatively and post-operatively in all study participants. Major complications include mortality, cerebellar contusion, facial palsy, meningitis, lower cranial neuropathy, hydrocephalus, pseudomeningocele and CSF leak. Minor complications include transient hydrocephalus, wound seroma, minor infections, balance problems, transient nerve palsies, transient dysphonia or difficulty swallowing, headache, flap problems, and non-auditory side effects. These complications will be tracked through serial clinical exams as well as patient recorded questionnaires to determine the safety profile of ABI surgery.
5 years from date of surgery
Yes
United States: Food and Drug Administration
13-028H
NCT01864291
May 2013
November 2022
Name | Location |
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Massachusetts Eye and Ear Infirmary | Boston, Massachusetts 02114-3096 |