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

F

FDA Office of Orphan Products Development

Status and phase

Completed
Phase 1

Conditions

Neurofibromatosis 2

Treatments

Device: Penetrating auditory brainstem implant

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00030043
FD-R-001969-01

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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