New ear test could improve hearing implant success
NCT ID NCT07557771
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
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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
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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