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

NCT07458477 | Completed

• 1 other identifier: CHM-2024/S33/05
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Audiometric tests; Hearing Space Audiometer

Outcome Measures

Primary Outcomes (1)

• auditory threshold levels and speech recognition thresholds

  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)

Study Arms (2)

Hearing Space audiometer first

EXPERIMENTAL

Hearing Space audiometer first, then AC40 audiometer

Device: Hearing Space audiometer first, then AC40 audiometer

AC40 audiometer first

EXPERIMENTAL

AC40 audiometer first, then Hearing Space audiometer

Device: AC40 audiometer first, then Hearing Space audiometer

Interventions

Hearing Space audiometer first, then AC40 audiometer DEVICE

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

Hearing Space audiometer first

AC40 audiometer first, then Hearing Space audiometer DEVICE

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

AC40 audiometer first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre hospitalier du Mans

Le Mans, 72000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: November 7, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-03

Locations

FR (1)