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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06378632 on ClinicalTrials.gov