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

NCT07458477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-07-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Hospitalier le Mans

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2026-01-12
Completion
2026-01-12

Countries

  • France

Study Locations

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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 NCT07458477 on ClinicalTrials.gov