An observational study in Conductive Hearing Loss, Middle Ear, sponsored by Audioptics Medical Incorporated. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by Audioptics Medical Incorporated · Observational
The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. The targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss.
The main questions the study aims to answer are:
Participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. Standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants.
Minimum 120 normal-hearing subjects including at least 10 male and 10 female subjects in each age group 18-30, 30-40, 40-50, 50-60 and 60+
Exclusion Criteria:
Diagnostic Test: Ossicular mobility measurement
Measurements of ossicular mobility i.e. the dynamic velocity of middle ear structures (umbo of malleus and incus at the incudostapedial joint) normalized to sound pressure incident on the tympanic membrane.
Umbo mobility
Estimated mean and variance of mobility in mm/s/Pa in the normal-hearing population measured at the umbo of the malleus at 500Hz, 750Hz, 1000Hz, 1500Hz, 2000Hz and 3000Hz stimulus frequencies.
Time frame: At study completion (6 months)
Incus mobility
Estimated mean and variance of mobility in mm/s/Pa in the normal-hearing population measured at the incus lateral to the incudostapedial joint at 500Hz, 750Hz, 1000Hz, 1500Hz, 2000Hz and 3000Hz stimulus frequencies.
Time frame: At study completion (6 months)
Dependence on age and sex
p-values for dependence on age, sex and age-sex interaction at each stimulus frequency within two-way ANOVA.
Time frame: At study completion (6 months)
Plan to share: No
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Audioptics Medical Incorporated