Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030043
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-30
Brief Title:
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Penetrating Auditory Brainstem Implant for Neurofibromatosis 2
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The PABI may be placed surgically during tumor resection Efficacy will be assessed using psychophysical and standard speech reception measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None