Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

FDA Office of Orphan Products Development3 sites in 1 country10 target enrollmentSeptember 2001

ConditionsNeurofibromatosis 2

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Neurofibromatosis 2
Sponsor: FDA Office of Orphan Products Development
Enrollment: 10
Locations: 3
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

August 2003

Last Updated

11 years ago

Study Type

Interventional

Sex

All