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An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
This study has been completed.
Study NCT00030043   Information provided by FDA Office of Orphan Products Development
First Received: January 30, 2002   Last Updated: January 31, 2006   History of Changes

January 30, 2002
January 31, 2006
September 2001
 
 
 
Complete list of historical versions of study NCT00030043 on ClinicalTrials.gov Archive Site
 
 
 
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

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.

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.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Neurofibromatosis 2
Device: Penetrating auditory brainstem implant
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
August 2003
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030043
 
FD-R-001969-01
FDA Office of Orphan Products Development
 
 
FDA Office of Orphan Products Development
January 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP