Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004437
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Patients are followed every 3 months for the first year then annually thereafter
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CC-FDR001283 | None | None | None |