Wideband tympanometry to measure how well speech passes through the middle ear

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

This trial will see if wideband tympanometry can measure how well speech travels through the middle ear in adults with conductive hearing loss, normal-hearing adults, and cochlear implant recipients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 1 site (Leuven)
• Trial ID: NCT07557771 on ClinicalTrials.gov

What this trial studies

The trial uses wideband tympanometry (WT), a non-invasive measure of middle-ear impedance across a broad range of pressures and frequencies, to capture speech-weighted transfer characteristics. Participants include adults with conductive hearing loss, normal-hearing controls, and cochlear implant recipients who undergo WT alongside standard audiometry and classical tympanometry. WT results will be correlated with audiometric measures and derived speech-weighted middle ear transfer functions to determine whether WT provides an objective, non-behavioral estimate of speech conduction. All testing is performed in-person at UZ Leuven under informed consent.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with conductive hearing loss being considered for middle ear implants, plus normal-hearing adults and cochlear implant users who serve as comparison groups.

Not a fit: Patients with purely sensorineural hearing loss, young children, or people unable to complete in-person ear testing are unlikely to receive direct benefit from this measure.

Why it matters

Potential benefit: If successful, WT could give clinicians a quick, objective way to estimate speech conduction through the middle ear and help select or plan middle ear implants.

How similar studies have performed: Previous research supports wideband tympanometry for detailed middle-ear characterization, but using WT specifically to predict speech-weighted transfer for implant candidacy is relatively novel.

Eligibility criteria

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

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (RECRUITING)

Conditions: Conductive Hearing Loss