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

NCT07557771 | Recruiting

• 4 other identifiers: S702721S16625N1804826NHBC.2023.0899
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Conductive Hearing Loss

Outcome Measures

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.

  5 minutes

Study Arms (3)

conductive hearing loss

EXPERIMENTAL

patients with isolated conductive hearing loss

Device: Wideband Tympanometry

normal hearing

EXPERIMENTAL

persons with normal hearing

Device: Wideband Tympanometry

cochlear implant recipients

EXPERIMENTAL

patients who undergo cochlear implantation

Device: Wideband Tympanometry

Interventions

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.

cochlear implant recipients; conductive hearing loss; normal hearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are allocated to one of three groups (conductive hearing loss, normal hearing, CI recipient) according to their hearing status. Hence, allocation is non-randomized. All patients undergo the same intervention: Wideband Tympanometry.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 29, 2026
• Study Start: July 4, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-11

Locations

BE (1)