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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Air-conduction hearing threshold at all frequencies ≤15dB.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: conductive hearing lossExperimental treatment 1 intervention
Group B: normal hearingExperimental treatment 1 intervention
Group C: cochlear implant recipientsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
5 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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