NCT07458477

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Centre Hospitalier le Mans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Audiometric Tests

Interventions

Type	Name	Description
DEVICE	Hearing Space audiometer first, then AC40 audiometer	All patients will be tested by Hearing Space audiometer first, then AC40 audiometer
DEVICE	AC40 audiometer first, then Hearing Space audiometer	All patients will be tested by AC40 audiometer first, then Hearing Space audiometer

Timeline

• Start date: 2025-11-07
• Primary completion: 2026-04-07
• Completion: 2026-04-07
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: France