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Breakthrough device aims to catch 'Invisible' hearing loss before It's too late

NCT ID NCT06114680

Diagnosis Sponsor: University Ghent 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new device called the CochSyn test prototype, which measures brain responses to sound to detect a type of hidden hearing loss called cochlear synaptopathy. The goal was to see if it could identify hearing problems earlier than standard hearing tests. The study enrolled 179 adults with self-reported hearing difficulties. However, the trial was terminated, so the full results are not available.

What this could mean

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

What this could lead to
If successful, this test could help diagnose a type of hearing loss that standard hearing tests miss, potentially leading to earlier and more targeted treatment.
What could go wrong
The trial was terminated, so results are incomplete. The test is still a prototype and may not prove more effective than existing methods.

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

179 people

The number who actually took part.

Started

Nov 2023

Finished

Dec 2025

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 to 87 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Session 1 Test group * 18 - 87 years old * Flemish/Dutch as native language * Ability to fill out a questionnaire and to perform a speech intelligibility test * Self-reported hearing difficulties according to HHIE-s questionnaire (score of \>4) * Normal audiogram (for age group 18-77): audiometric thresholds up to 4 kHz ≤ 20 dB HL and for 6 kHz ≤ 40 dB HL in at least 1 ear OR impaired audiogram (for age group 18-87): audiometric thresholds between 20.1 and 64.9 dB HL pure tone average at 0.5, 1, 2, and 4 kHz in at least 1 ear (=Mild to moderately severe hearing loss according to the recommendation by the Global Burden of Disease Expert Group on Hearing Loss) Control group * 18 - 77 years old * Flemish/Dutch as native language * Ability to fill out a questionnaire and to perform a speech intelligibility test * No self-reported hearing difficulties according to HHIE-s questionnaire (score of ≤4) * Normal audiogram: audiometric thresholds up to 4 kHz ≤ 20 dB HL and for 6 kHz ≤ 40 dB HL in at least 1 ear Session 2 * Participation in session 1 in the test group * 18 - 77 years old * EFR magnitude at 4 kHz with Snap electrode in session 1 reduced by 30-100% compared to average EFR magnitude of age group 18-27 of control group (session 1) Exclusion Criteria: Applicable for both sessions: * Pregnant woman * Breastfeeding woman Applicable for both sessions and the ear which fulfils the inclusion criteria: * Chronic (longer than 6 months) permanent tinnitus * Hearing loss due to a genetic condition, a middle ear condition, or surgery * Congenital hearing loss * Blocked ear canal

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Conditions

The condition(s) this trial relates to.

Hearing Loss, Hidden Hearing Loss, Sensorineural sensorineural hearing loss disorder

As listed by the trial registrant

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

Cochlear hearing loss Cochlear synaptopathy Hearing loss, sensorineural

Contacts and locations

Locations

  • UZ Gent - department of otorhinolaryngology

    Ghent, 9000, Belgium

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