Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030043
Recruitment Status : Completed
First Posted : January 31, 2002
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Neurofibromatosis 2 Device: Penetrating auditory brainstem implant Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Penetrating Auditory Brainstem Implant for Neurofibromatosis 2
Study Start Date : September 2001
Study Completion Date : August 2003

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030043

Layout table for location information
United States, California
House Ear Institute
Los Angeles, California, United States, 90057
Huntington Medical Research Institutes
Pasadena, California, United States
United States, Colorado
Cochlear Corporation
Englewood, Colorado, United States
Sponsors and Collaborators
FDA Office of Orphan Products Development

Layout table for additonal information Identifier: NCT00030043     History of Changes
Other Study ID Numbers: FD-R-001969-01
First Posted: January 31, 2002    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: January 2002
Keywords provided by FDA Office of Orphan Products Development:
Electric Stimulation
Implants, Artificial
Speech Perception
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurofibromatosis 1
Neurofibromatosis 2
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Neoplasms