AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
NCT06378632 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2025-03-26
Summary
Study Design:
This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.
Conditions
Interventions
- DEVICE
-
Hearo App
No intervention - only data collection
Sponsors & Collaborators
-
Cordio Medical
lead INDUSTRY
Principal Investigators
-
Ronit Haviv, PhD · Cordio Medical
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-11
- Primary Completion
- 2025-07-01
- Completion
- 2025-07-15
- FDA Device
- Yes
Countries
- United States
- Israel
- Spain
Study Locations
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