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

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.

Study Overview

• Status: Recruiting
• Conditions: Conductive Hearing Loss
• Intervention / Treatment: Device: Wideband Tympanometry

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Nathan Goedseels, MD; Phone Number: +32 471 05 12 36; Email: nathan.goedseels@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conductive hearing loss; patients with isolated conductive hearing loss	Device: Wideband 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.
Experimental: normal hearing; persons with normal hearing	Device: Wideband 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.
Experimental: cochlear implant recipients; patients who undergo cochlear implantation	Device: Wideband 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Conductive
• Other Study ID Numbers: S70272; 1S16625N (Other Grant/Funding Number: Fonds Wetenschappelijk Onderzoek); 1804826N (Other Grant/Funding Number: Fonds Wetenschappelijk Onderzoek); HBC.2023.0899 (Other Grant/Funding Number: VlAIO - Vlaams Agentschap Innoveren en Ondernemen)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No