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

Neurofibromatosis 2 Clinical Trial

Official title:

Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030043
• Other study ID #: FD-R-001969-01
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: August 2003

Study information

• Verified date: January 2002
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 2

Intervention

Device:
• Penetrating auditory brainstem implant

Locations

Country	Name	City	State
United States	Cochlear Corporation	Englewood	Colorado
United States	House Ear Institute	Los Angeles	California
United States	Huntington Medical Research Institutes	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development

Country where clinical trial is conducted

United States,