Reliability of a Portable Audiometric Device Based on Active Noise-Canceling Headphones for Clinical Hearing Assessment

What this Trial Is About

Hearing loss affects around 500 million people worldwide and poses a significant health challenge. Early detection and intervention are key to managing hearing loss, but current standard testing requires soundproof rooms and professional audiologists, which many primary hospitals lack. Researchers are evaluating a novel portable hearing testing device (E200) that combines active and passive noise reduction, allowing hearing tests in noisier environments and enabling use by non-professionals with automatic calibration. This study aims to verify the reliability of this new device in assessing hearing conditions. Participants will undergo two hearing tests: the conventional pure tone audiometry in a soundproof booth using standard equipment, and the E200 audiometry in a regular room with higher ambient noise, simulating everyday environments. Both tests use the Hughson-Westlake method and contralateral masking when needed. The order of testing is randomized with at least a 10-minute gap to reduce fatigue. Each test lasts about 6 to 8 minutes. Volunteers will be recruited from outpatient and inpatient departments, providing consent and basic information including hearing status and ear history. They will receive ear examinations and physical assessments. Researchers will monitor reactions during testing to ensure comfort and safety. The primary outcome is comparing hearing thresholds across frequencies between the two testing methods. The study ensures confidentiality and follows ethical guidelines, with participation lasting from enrollment until the end of testing and follow-up as needed.

Reliability of a Portable Audiometric Device Based on Active Noise-Canceling Headphones for Clinical Hearing Assessment