Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07458477

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

Led by Centre Hospitalier le Mans · Updated on 2026-03-09

52

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have come to the ENT department for an audiometric examination
  • Adult patients aged 18 or over, regardless of weight, gender, ethnicity, etc.
  • Patients whose native language is French
  • Able to understand instructions
  • Person affiliated with or beneficiary of a social security system
  • Free, informed, and written consent signed by the participant and investigator before any examination required by the research
Not Eligible

You will not qualify if you...

  • Patients with known or confirmed unilateral cochlear deafness
  • Adults deprived of liberty or under guardianship
  • Pregnant women
  • Patients with only one ear

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre hospitalier du Mans

Le Mans, France, 72000

Actively Recruiting

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Research Team

C

Christelle JADEAU

CONTACT

N

Nadya EMAM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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