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New treatment option for Conductive Hearing Loss
Official title Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.
ClinicalTrials.gov ID: NCT07557771
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- NH people
- 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.
You likely can't join if
- NH people
- 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 treatment Trial with an investigational medicinal product (IMP) or device
See the full eligibility criteria
- NH people
- 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 people
- 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.
- NH people
- 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 treatment Trial with an investigational medicinal product (IMP) or device
- CHL people
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.