Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02102256
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2014-03-19
Brief Title:
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Sponsor:
Laurie Eisenberg
Organization:
University of Southern California
Study Overview
Official Title:
A Feasibility Study of the Placement Use and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 NF2 Pediatric Patients
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Current treatment options for bilateral profoundly deaf children diagnosed with inner ear anatomical abnormalities are limited and in the case of absent cochleas non-existent An auditory brainstem implant ABI places an electrode close to the auditory nucleus in the brainstem Children aged 2 - 5 who are not candidates for a cochlear implant or who did not demonstrate benefit from a cochlear implant will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy This is a feasibility study to determine the safety of the ABI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None