NCT00004437

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurofibromatosis 2

Interventions

Type	Name	Description
DEVICE	Multichannel Auditory Brain Stem Implant

Timeline

• Start date: 1999-10-01
• Completion: 2000-10-01
• First posted: 1999-10-19
• Last updated: 2015-03-25