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
Neurofibromatosis 2	Device: Penetrating auditory brainstem implant	Phase I

Further Study Details: 

Expected Total Enrollment:  10

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Chris van den Honert, Ph.D.      303-362-2114 

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

Study ID Numbers:  FD-R-001969-01
Record last reviewed:  January 2002
Last Updated:  October 13, 2004
Record first received:  January 30, 2002
ClinicalTrials.gov Identifier:  NCT00030043
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08