Ossiview Normative Mobility Data Collection Protocol

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: * What are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus? * Are there any significant differences in these vibrational responses associated with sex or age? 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.

NCT Number	NCT06310278
Lead Sponsor	Audioptics Medical Incorporated
Conditions	Conductive Hearing Loss, Middle Ear
Enrollment	120 participants
Start Date	2024-05-09
Primary Completion	2024-10-31 (estimated)
Study Completion	2024-10-31 (estimated)
Updated on ClinicalTrials.gov	2024-08-01