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Home > "A" Clinical Trials Conditions > An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors  An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
For Condition: Neurofibromatosis 2
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 10
Location and Contact Information:
House Ear Institute *Recruiting*
Los Angeles, California, 90057
United States
Recruiting
Cochlear Corporation *Recruiting*
Englewood, Colorado,
United States
Recruiting
Huntington Medical Research Institutes *Recruiting*
Pasadena, California,
United States
Recruiting
Additional Information:
Study ID Numbers: FD-R-001969-01;
Study Start Date: September 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030043
Other Neurofibromatosis 2 Studies:
1. NF2 Natural History Consortium
2. An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
3. Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2
Related Studies:
Other Neurofibromatosis 2 Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
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