Clinical Trial: An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

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 Summary:

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.

Sponsor: FDA Office of Orphan Products Development

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: January 30, 2002
Date Started: September 2001
Date Completion: August 2003
Last Updated: March 24, 2015
Last Verified: January 2002