Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT05876533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2023-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
Sponsor:
Cordio Medical
Organization:
Study Overview
Official Title:
An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
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:
To determine the usability and technical aspects of Cordio HearO™
Detailed Description:
The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.
The recordings data will also be used for algorithm improvement
The recordings data will also be used for algorithm improvement
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: