Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2

FDA Office of Orphan Products Development0 sitesOctober 1999

ConditionsNeurofibromatosis 2

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Neurofibromatosis 2
Sponsor: FDA Office of Orphan Products Development
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this information to better program the auditory brain stem implant for an individual.

II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual psychoacoustic channels for each patient, to increase the number of usable information channels for each patient and reduce or eliminate undesirable side effects.

III. Evaluate performance and learning effects using optimized fitting procedures.

Detailed Description

PROTOCOL OUTLINE: Patients undergo surgery to remove the first side or second side tumor, during which the multichannel auditory brain stem implant is implanted. Initial stimulation is conducted 4-6 weeks after surgery. Patients are followed every 3 months for the first year, then annually thereafter.

Registry

clinicaltrials.gov

Start Date

October 1999

End Date

October 2000

Last Updated

11 years ago

Study Type

Interventional

Sex

All