Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310278
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-02
Brief Title:
Ossiview Normative Mobility Data Collection Protocol
Sponsor:
Audioptics Medical Incorporated
Organization:
Audioptics Medical Incorporated
Study Overview
Official Title:
Ossiview Normative Mobility Data Collection Protocol
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None