Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07557771

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Conductive Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wideband Tympanometry

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

BREEDBAND TYMPANOMETRIE ALS EEN NIET-GEDRAGSMATIGE TEST VAN DE SPRAAK-GEWOGEN MIDDENOOR TRANSFER FUNCTIE.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.