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

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
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In plain words

What the trial is, and whether it could suit you

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 ass

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค15dB. * 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 โ‰ค20dB. * Two exceptions: * Age-related hearing loss: bone-conduction threshold โ‰ค40dB in the higher frequencies (\> 2kHz). * Carhart notch: bone-conduction threshold \>20dB around 2kHz. air-bone-gap โ‰ฅ10dB at โ‰ฅ 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
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What it tests

  • Wideband Tympanometry
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Where

1 site
UZ Leuven
Leuven, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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