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

March 4, 2026 updated by: Centre Hospitalier le Mans

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier du Mans
        • Contact:
        • Principal Investigator:
          • Nadya EMAM, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 the investigator (no later than the day of inclusion and before any examination required by the research).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearing Space audiometer first
Hearing Space audiometer first, then AC40 audiometer
Device: Hearing Space audiometer first, then AC40 audiometer
All patients will be tested by Hearing Space audiometer first, then AC40 audiometer
Experimental: AC40 audiometer first
AC40 audiometer first, then Hearing Space audiometer
Device: AC40 audiometer first, then Hearing Space audiometer
All patients will be tested by AC40 audiometer first, then Hearing Space audiometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
auditory threshold levels and speech recognition thresholds
Time Frame: From inclusion to the end of the intervention (40 minutes on average)

Measurements of pure-tone audiometric thresholds and speech recognition thresholds will be taken for each of the patient's ears using the Hearing Space digital audiometer and the Interacoustic AC40 physical audiometer (in random order).

The results obtained will then be statistically compared to determine whether or not there is a significant difference between the results obtained by the two devices.
From inclusion to the end of the intervention (40 minutes on average)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

April 7, 2026

Study Completion (Estimated)

April 7, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHM-2024/S33/05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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