Digital Audiometer vs. Conventional Audiometer (Gold Standard): Study of Tonal and Vocal Recognition Thresholds

According to the WHO (February 2, 2024): More than 5% of the world's population, or 430 million people (including 34 million children), need rehabilitation services due to disabling hearing loss. It is estimated that 700 million people will be affected by 2050, or one in 10 people. It is estimated that by 2050, nearly 2.5 billion people will have some degree of hearing loss. In most cases, audiometric testing involves determining the patient's tonal thresholds and speech recognition thresholds. The Hearing Space device is a digital audiometer that can perform both tonal and speech audiometry. This device stands out because it allows users to calibrate its transducers themselves via a guided, automated procedure. This procedure ensures that the calibration complies with the relevant calibration standards.

NCT Number	NCT07458477
Lead Sponsor	Centre Hospitalier le Mans
Conditions	Audiometric Tests
Enrollment	53 participants
Start Date	2025-11-07
Primary Completion	2026-01-12 (estimated)
Study Completion	2026-01-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-01