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

Penetrating Auditory Brainstem Implant for Neurofibromatosis 2

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00030043
Enrollment
10
Registered
2002-01-31
Start date
2001-09-30
Completion date
2003-08-31
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis 2

Keywords

Electric Stimulation, Implants, Artificial, Brainstem, Electrodes, Speech Perception

Brief 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.

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.

Interventions

DEVICEPenetrating auditory brainstem implant

Sponsors

FDA Office of Orphan Products Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026