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New ear test could improve hearing implant success

NCT ID NCT07557771

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing a device called Wideband Tympanometry to see if it can measure how well the middle ear conducts speech without requiring the patient to respond. Researchers will compare these measurements with standard speech tests in 45 adults with normal hearing or conductive hearing loss. The goal is to create a better tool for deciding who might benefit from middle ear implants.

What this could mean

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

Active substance
Wideband Tympanometry device
What this could lead to
If successful, this could provide a simple, non-behavioral test to help doctors better select patients for middle ear implants.
What could go wrong
This is a small, early-stage study (45 participants) focused on measurement accuracy, not treatment. The test may not reliably predict speech transfer in all cases.

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

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

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

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: * NH subjects * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. * At least 18 years of age at the time of signing the ICF. * Pure tone audiometry: * Air-conduction hearing threshold at all frequencies ≤15dB. * No air-bone-gap. * Normal classical tympanometry: Jerger A (see fig. 1) * CHL subjects * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. * At least 18 years of age at the time of signing the ICF. * Pure tone audiometry: * Bone-conduction threshold at all frequencies ≤20dB. * Two exceptions: * Age-related hearing loss: bone-conduction threshold ≤40dB in the higher frequencies (\> 2kHz). * Carhart notch: bone-conduction threshold \>20dB around 2kHz. air-bone-gap ≥10dB at ≥ 1 frequency. * CI recipients * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. * At least 18 years of age at the time of signing the ICF. * Ear is planned for CI surgery by treating ENT surgeon. * Normal classical tympanometry: Jerger A. Exclusion Criteria * NH subjects * Patient has history of extensive middle ear disease. * Patient has history of middle ear surgery. * Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion. * Severe otitis externa or occlusion of the external auditory canal * Participation in an interventional Trial with an investigational medicinal product (IMP) or device * CHL subjects * Patient has history of middle ear surgery. * Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion. * Signs of structural pathological processes such as tumors, cysts or cholesteatoma. * Severe otitis externa or occlusion of the external auditory canal * Participation in an interventional Trial with an investigational medicinal product (IMP) or device * CI recipients * ear has history of extensive middle ear disease. * ear has history of middle ear surgery. * Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion. * Severe otitis externa or occlusion of the external auditory canal

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Conditions

The condition(s) this trial relates to.

conductive hearing loss disorder Hearing Loss, Conductive

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

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