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Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-29
45
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old at the time of consent.
- Normal hearing (NH) subjects must have air-conduction hearing thresholds ≤15 dB at all frequencies and no air-bone gap.
- NH subjects must have normal classical tympanometry classified as Jerger A.
- Conductive hearing loss (CHL) subjects must have bone-conduction thresholds ≤20 dB at all frequencies, with exceptions for age-related hearing loss and Carhart notch.
- CHL subjects must have an air-bone gap ≥10 dB at one or more frequencies.
- Cochlear implant (CI) recipients must have normal classical tympanometry Jerger A and be planned for CI surgery by an ENT surgeon.
- All participants must provide voluntary written informed consent prior to screening procedures.
You will not qualify if you...
- NH subjects with a history of extensive middle ear disease or middle ear surgery are excluded.
- NH subjects with abnormal otoscopy showing tympanic membrane perforation or middle ear effusion are excluded.
- NH subjects with severe otitis externa or occlusion of the external auditory canal are excluded.
- Participation in interventional trials with investigational medicinal products or devices is excluded.
- CHL subjects with a history of middle ear surgery are excluded.
- CHL subjects with abnormal otoscopy showing tympanic membrane perforation or middle ear effusion are excluded.
- CHL subjects with structural pathologies such as tumors, cysts, or cholesteatoma are excluded.
- CHL subjects with severe otitis externa or occlusion of the external auditory canal are excluded.
- CI recipients with a history of extensive middle ear disease or middle ear surgery are excluded.
- CI recipients with abnormal otoscopy showing tympanic membrane perforation or middle ear effusion are excluded.
- CI recipients with severe otitis externa or occlusion of the external auditory canal are excluded.
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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