An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors - Tabular View

Tracking Information
First Received Date ^ICMJE	January 30, 2002
Last Updated Date	January 31, 2006
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00030043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
Official Title ^ICMJE	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 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.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Condition ^ICMJE	Neurofibromatosis 2
Intervention ^ICMJE	Device: Penetrating auditory brainstem implant
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	10
Completion Date	August 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria: Diagnosis of neurofibromatosis type 2 Speak English as a primary language Exclusion criteria: Physical, psychological, or medical conditions that contraindicate the surgical procedure
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00030043
Responsible Party
Study ID Numbers ^ICMJE	FD-R-001969-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	January 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP