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RecruitingNCT07557771Updated Apr 29, 2026

Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.

An interventional study of Wideband Tympanometry in Conductive Hearing Loss, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2025, registered Apr 2026).
  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Conductive Hearing Loss
03

In context

Hearing Loss, Conductive

82 studies on the registry are indexed under Hearing Loss, Conductive; 15 are open to participants now.

This study's planned enrollment of 45 is above the median of 30 across 59 interventional studies indexed under Hearing Loss, Conductive.

Browse Hearing Loss, Conductive studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Universitaire Ziekenhuizen KU Leuven studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • NH subjects
  • Voluntary written 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

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    conductive hearing loss

    patients with isolated conductive hearing loss

    Device: Wideband Tympanometry

  • Experimental
    normal hearing

    persons with normal hearing

    Device: Wideband Tympanometry

  • Experimental
    cochlear implant recipients

    patients who undergo cochlear implantation

    Device: Wideband Tympanometry

Interventions

  • DeviceWideband Tympanometry

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Nov 2027, 28 months after the start.

Of 37 interventional studies with no phase under Hearing Loss, Conductive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 25. This study's planned 28 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2026
First posted
Apr 29, 2026
StartActual
Jul 4, 2025
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07557771
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
Jul 4, 2025
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Apr 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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