Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function. (NCT07557771) | Clinical Trial Compass
RecruitingNot Applicable
Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.
Belgium45 participantsStarted 2025-07-04
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 exte…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wideband Absorbance as measured with Wideband Tympanometry