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OpenTrials
Completed

NCT Number: NCT07458477

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.

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Key information

Conditions

Audiometric Tests

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier du Mans

Le Mans, 72000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing Space audiometer first, then AC40 audiometer

Device

All patients will be tested by Hearing Space audiometer first, then AC40 audiometer

AC40 audiometer first, then Hearing Space audiometer

Device

All patients will be tested by AC40 audiometer first, then Hearing Space audiometer

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: LHS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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