Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2
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.
Device: Multichannel Auditory Brain Stem Implant
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||October 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004437
|Study Chair:||Steven J. Staller||Cochlear|