Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04890145
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-05-12
Brief Title:
The RW-Precision-Coupler Clinical Investigation
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
MED-EL Elektromedizinische Geräte GesmbH
Study Overview
Official Title:
The RW-Precision-Coupler Clinical Investigation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
The RW-Precision-Coupler Clinical Investigation is prospective non-randomized open label single subjects repeated measures longitudinal monocentric trial The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the treatment of hearing loss As secondary aims are to evaluate the clinical performance of VSB together with RWP-Coupler by measuring Sound Field audiometry SF to evaluate the safety of VSB together with RWP-Coupler by measuring bone conduction BC thresholds and collecting and assessing adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None