Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT03902093
Status:
WITHDRAWN
Last Update Posted:
2021-12-15
First Post:
2019-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morphology Effects of Extended Wear Hearing Instrument
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Longitudinal Study of External Auditory Canal Morphology With Regards to Extended-wear Hearing Instrument
Status:
WITHDRAWN
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study is withdrawn due to no enrollment, due to COVID pandemic.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The lyric hearing device is a commercially available device produced by Sonova, and designed to be used for extended periods of time. We further want to investigate the morphology of the tissue around the device at different periods of time after the device has been fitted and used for a while.
An initial imaging of the tissue will be taken for baseline measurements. Questionnaires will also be used to assess patients satisfaction with the device and cognitive abilities.
An initial imaging of the tissue will be taken for baseline measurements. Questionnaires will also be used to assess patients satisfaction with the device and cognitive abilities.
Detailed Description:
If the person seems to be a good candidate for the study, the Audiologist could discuss with the patient the time involved in the study and arrange an appointment with the patient if interested.
A series of appointments are designed to follow up the patient's development with the device at determined times during the process. On the first appointment the patient will be consented prior to any tests or health services given.
The first and last appointments are the longest ones with a duration of about 1 and a half hours for questionnaires, medical history, and device fitting. Additionally, all appointments include measurement of ear canal relative humidity which should take a total of 30 minutes and imaging of the area to determine thickness and blood flow in the tissue surrounding the device. Follow-up appointments with the Audiologist will take 45 minutes for all basic procedures. The Lyric device is used commercially and Audiologist can provide it to patients already, but the purpose of this study is to use a pioneer technique with a device that looks inside the ear canal in the same way as a regular used speculum to look at details of the tissue around the device to see if any changes occur due to extended wear of the Lyric hearing aid device.
The complete study per person will be completed in about six months. An Audiologist will perform all the audiology testing plus the ear canal humidity measurements and his/her time will be covered by the sponsor (a total of 9 hours per patient). The Lyric devices will be provided on loan by the sponsor as well as the equipment and software needed to make the ear canal humidity measurements. The imaging measurements will be conducted by the Audiologist trained in using the handheld device.
A series of appointments are designed to follow up the patient's development with the device at determined times during the process. On the first appointment the patient will be consented prior to any tests or health services given.
The first and last appointments are the longest ones with a duration of about 1 and a half hours for questionnaires, medical history, and device fitting. Additionally, all appointments include measurement of ear canal relative humidity which should take a total of 30 minutes and imaging of the area to determine thickness and blood flow in the tissue surrounding the device. Follow-up appointments with the Audiologist will take 45 minutes for all basic procedures. The Lyric device is used commercially and Audiologist can provide it to patients already, but the purpose of this study is to use a pioneer technique with a device that looks inside the ear canal in the same way as a regular used speculum to look at details of the tissue around the device to see if any changes occur due to extended wear of the Lyric hearing aid device.
The complete study per person will be completed in about six months. An Audiologist will perform all the audiology testing plus the ear canal humidity measurements and his/her time will be covered by the sponsor (a total of 9 hours per patient). The Lyric devices will be provided on loan by the sponsor as well as the equipment and software needed to make the ear canal humidity measurements. The imaging measurements will be conducted by the Audiologist trained in using the handheld device.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: