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New digital audiometer could make hearing tests easier and more accessible

NCT ID NCT07458477

Diagnosis Sponsor: Centre Hospitalier le Mans Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study is testing a new digital audiometer called Hearing Space against the standard AC40 device to see if it can accurately measure hearing loss. Researchers will test 52 adults in an ENT department, checking both pure-tone and speech recognition thresholds. The goal is to see if the digital device, which can self-calibrate, gives results as reliable as the conventional machine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hearing Space digital audiometer
What this could lead to
If successful, this could show that a self-calibrating digital audiometer is a reliable, accessible alternative for hearing tests, potentially expanding screening options.
What could go wrong
This is a small, early-stage comparison study (52 participants) focused on accuracy, not treatment. The digital device may not match the gold standard in all cases, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

53 people

The number who actually took part.

Started

Nov 2025

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Audiometric tests

Contacts and locations

Locations

  • Centre hospitalier du Mans

    Le Mans, 72000, France

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