Penetrating Auditory Brainstem Implant for Neurofibromatosis 2
Neurofibromatosis Type 2 (NF2) is characterized by multiple tumors of the cranial and spinal
nerves, and, in particular, by bilateral acoustic tumors. Surgical resection of these tumors
generally results in the transection of the VIIIth nerve, destruction of the cochlea and
auditory nerve, and total hearing loss. Due to the loss of the auditory nerve, these
patients are not candidates for cochlear implantation. The Auditory Brainstem Implant (ABI)
provides the only available intervention to restore some auditory sensation to these
patients. An ABI is an implantable prosthesis that produces sound sensation by electrical
stimulation of the ascending auditory pathway at the level of the cochlear nucleus.
The PABI may be placed surgically during tumor resection. Efficacy will be assessed using
psychophysical and standard speech reception measures.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
FD-R-001969-01
NCT00030043
September 2001
August 2003
Name | Location |
---|---|
House Ear Institute | Los Angeles, California 90057-9927 |
Huntington Medical Research Institutes | Pasadena, California |
Cochlear Corporation | Englewood, Colorado |