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.

Study Overview

• Status: Completed
• Conditions: Neurofibromatosis 2
• Intervention / Treatment: Device: Penetrating auditory brainstem implant

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 Type: Interventional
• Enrollment: 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • House Ear Institute
    • Pasadena, California, United States
      • Huntington Medical Research Institutes
  • Colorado
    • Englewood, Colorado, United States
      • Cochlear Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: FDA Office of Orphan Products Development

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Study Completion: August 1, 2003

Study Registration Dates

• First Submitted: January 30, 2002
• First Submitted That Met QC Criteria: January 30, 2002
• First Posted (Estimate): January 31, 2002

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: January 1, 2002

More Information

Terms related to this study

• Keywords: Speech Perception; Electric Stimulation; Brainstem; Electrodes; Implants, Artificial
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuromuscular Diseases; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neurodegenerative Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Ear Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Cranial Nerve Diseases; Neuroendocrine Tumors; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neuroma, Acoustic; Neurilemmoma; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurofibromatosis 2
• Other Study ID Numbers: FD-R-001969-01