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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Flexible bandage-style conductive hearing aid for conductive hearing loss

  This study will test a flexible, Band-Aid–like conductive hearing aid for children and adults with permanent conductive or mixed hearing loss to see if it improves comfort and hearing without surgery.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07222202

• Transitioning from Baha Connect to Osia System in adults with mixed or conductive hearing loss

  This study tests whether the Osia System is safe and performs well in adults who already use a Baha Connect system and want to switch.

  Recruiting at 2 sites Cochlear · London and 2 other locations · NCT07130136

• Hearing screening for preschool children

  This study is testing two different ways to check hearing in preschool children to see which method works better for finding hearing loss early and helping kids who might struggle with speech and language.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06058767

• Evaluating long-term effects of osseointegrated devices on hearing and cognition

  This study is trying to see how using special hearing devices affects the thinking and daily life of people with hearing loss over three years.

  Recruiting University of South Florida · Tampa, Florida · NCT04899037

• Surgical correlation for one-sided conductive hearing loss with an intact eardrum

  This test uses exploratory tympanotomy to see if the exact cause of one-sided conductive hearing loss with a normal eardrum can be found.

  Recruiting Al-Azhar University · Asyut, Asyut Governorate · NCT07431125

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.