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An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
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 | Treatment or Intervention | Phase |
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Neurofibromatosis 2 |
Device: Penetrating auditory brainstem implant |
Phase I |
MedlinePlus related topics: Acoustic Neuroma; Neurofibromatosis
Genetics Home Reference related topics: neurofibromatosis 2
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title: Penetrating Auditory Brainstem Implant for Neurofibromatosis 2
Expected Total Enrollment: 10
Study start: September 2001;
Study completion: August 2003
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
Exclusion criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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