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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07458477
Acronym
LHS
Enrollment
53
Registered
2026-03-09
Start date
2025-11-07
Completion date
2026-01-12
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Audiometric Tests

Keywords

Audiometric tests, Hearing Space Audiometer

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.

Interventions

DEVICEHearing Space audiometer first, then AC40 audiometer

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

DEVICEAC40 audiometer first, then Hearing Space audiometer

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

Sponsors

Centre Hospitalier le Mans
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
auditory threshold levels and speech recognition thresholdsFrom 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026