Conductive Hearing LossNCT07557771
Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.
A study testing Wideband Tympanometry in people with Conductive Hearing Loss, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
There is a need for a non-behavioral clinical test that provides an assessment of how speech is conducted through the middle ear for the optimization of middle ear implants. These implants utilize the functionality of the human middle ear and require adequate speech conduction through the middle ear chain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conductive Hearing Loss
- What is being tested?
- Wideband Tympanometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jul 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Nathan Goedseels, MD, +32 471 05 12 36, nathan.goedseels@kuleuven.be
About this study
Official title: BREEDBAND TYMPANOMETRIE ALS EEN NIET-GEDRAGSMATIGE TEST VAN DE SPRAAK-GEWOGEN MIDDENOOR TRANSFER FUNCTIE.
There is a need for a non-behavioral clinical test that provides an assessment of how speech is conducted through the middle ear for the optimization of middle ear implants. These implants utilize the functionality of the human middle ear and require adequate speech conduction through the middle ear chain. Consequently, the clinical test of this degree of speech transfer can contribute to the pre-operative indication for middle ear implants.
Wideband Tympanometry (WT) is a non-invasive diagnostic tool for the clinical assessment of the condition of the middle ear. Unlike classical tympanometry, WT tests the impedance of the middle ear system as a function of both pressure and frequencies. Consequently, a WT measurement contains many times more information about the functionality of the middle ear than classical tympanometry and is ideally suited as a diagnostic tool for the clinical assessment of speech transfer through the middle ear. The WT measurements will be correlated with the Speech Intelligibility Index (SII) collected in normally hearing individuals and patients with isolated conductive hearing loss. This index is a measure of speech transfer through the middle ear. Consequently, a correlation of the WT measurements with the SII addresses the need for a non-behavioral clinical test of speech transfer through the middle ear.
Additionally, WT measurements will be performed longitudinally in cochlear implant candidates, one of the populations that can benefit from the developed clinical test. These longitudinal WT measurements, which will be performed both pre- and post-operatively, allow for the evaluation of the impact of middle ear surgery on the predicted SII.
- Conditions
- Conductive Hearing Loss
- Being tested
- Wideband Tympanometry
- Medical subject headings
- Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wideband TympanometryDevice
Wideband Tympanometry evaluates the condition of the middle ear by measuring the middle ear's acoustic response in function of pressure and frequency. To this end, a probe containing a speaker, microphone and pressure pomp is gently inserted into the external ear canal. Tests are performed with a CE approved device.
| Study group | Role | What they receive |
|---|---|---|
| conductive hearing loss | Experimental | patients with isolated conductive hearing loss Receives: Device: Wideband Tympanometry |
| normal hearing | Experimental | persons with normal hearing Receives: Device: Wideband Tympanometry |
| cochlear implant recipients | Experimental | patients who undergo cochlear implantation Receives: Device: Wideband Tympanometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wideband Absorbance as measured with Wideband Tympanometry
Wideband Absorbance in function of frequency and pressure, as measured with Wideband Tympanometry. The device used is the Titan (interacoustics, Denmark). Frequency resolution is 503 logarithmically spaced frequency bins ranging from 226Hz up to 12000Hz and pressure points resolution depends on the sweep speed but varies between 200 and 210 points, equally spaced between -600daPa en +300daPa.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start4 Jul 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients are allocated to one of three groups (conductive hearing loss, normal hearing, CI recipient) according to their hearing status. Hence, allocation is non-randomized. All patients undergo the same intervention: Wideband Tympanometry.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557771
- Sponsor's protocol ID
- S70272
- Other IDs
- 1S16625N, 1804826N, HBC.2023.0899
- Status last verified
- Nov 2025
- First submitted
- 17 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREEDBAND TYMPANOMETRIE ALS EEN NIET-GEDRAGSMATIGE TEST VAN DE SPRAAK-GEWOGEN MIDDENOOR TRANSFER FUNCTIE.
- ClinicalTrials.gov ID
- NCT07557771
- Acronym / sponsor ID
- S70272
- Conditions
- Conductive Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a need for a non-behavioral clinical test that provides an assessment of how speech is conducted through the middle ear for the optimization of middle ear implants. These implants utilize the functionality of the human middle ear and require adequate speech conduction through the middle ear chain. Consequently, the clinical test of this degree of speech transfer can contribute to the pre-operative indication for middle ear implants.
Wideband Tympanometry (WT) is a non-invasive diagnostic tool for the clinical assessment of the condition of the middle ear. Unlike classical tympanometry, WT tests the impedance of the middle ear system as a function of both pressure and frequencies. Consequently, a WT measurement contains many times more information about the functionality of the middle ear than classical tympanometry and is ideally suited as a diagnostic tool for the clinical assessment of speech transfer through the middle ear. The WT measurements will be correlated with the Speech Intelligibility Index (SII) collected in normally hearing individuals and patients with isolated conductive hearing loss. This index is a measure of speech transfer through the middle ear. Consequently, a correlation of the WT measurements with the SII addresses the need for a non-behavioral clinical test of speech transfer through the middle ear.
Additionally, WT measurements will be performed longitudinally in cochlear implant candidates, one of the populations that can benefit from the developed clinical test. These longitudinal WT measurements, which will be performed both pre- and post-operatively, allow for the evaluation of the impact of middle ear surgery on the predicted SII.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients are allocated to one of three groups (conductive hearing loss, normal hearing, CI recipient) according to their hearing status. Hence, allocation is non-randomized. All patients undergo the same intervention: Wideband Tympanometry.
| Arm | Type | Receives |
|---|---|---|
| conductive hearing loss | Experimental | Device: Wideband Tympanometrypatients with isolated conductive hearing loss |
| normal hearing | Experimental | Device: Wideband Tympanometrypersons with normal hearing |
| cochlear implant recipients | Experimental | Device: Wideband Tympanometrypatients who undergo cochlear implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wideband TympanometryWideband Tympanometry evaluates the condition of the middle ear by measuring the middle ear's acoustic response in function of pressure and frequency. To this end, a probe containing a speaker, microphone and pressure pomp is gently inserted into the external ear canal. Tests are performed with a CE approved device. | Device | cochlear implant recipients, conductive hearing loss, normal hearing |
Primary outcome
Wideband Absorbance as measured with Wideband Tympanometry
Time frame: 5 minutes
Wideband Absorbance in function of frequency and pressure, as measured with Wideband Tympanometry. The device used is the Titan (interacoustics, Denmark). Frequency resolution is 503 logarithmically spaced frequency bins ranging from 226Hz up to 12000Hz and pressure points resolution depends on the sweep speed but varies between 200 and 210 points, equally spaced between -600daPa en +300daPa.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wideband Tympanometry in people with Conductive Hearing Loss, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wideband Absorbance as measured with Wideband Tympanometry (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.