Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-08-01
2023-06-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Hearing Aid
Actual Patients in the clinic will be evaluated by their Audiologist, if they are candidates to use the Lyric Hearing aid they will be asked if they want to participate in the study which will include imaging of the ear canal with a device similar to the regular ear device used in the clinic to check if there are any changes to the morphology of the ear canal.
Morphology changes with extended wear hearing aid
Possible changes in morphology due to wearing an extended wear hearing aid device will be assessed with imaging
Interventions
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Morphology changes with extended wear hearing aid
Possible changes in morphology due to wearing an extended wear hearing aid device will be assessed with imaging
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
Yes
Sponsors
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University of Southern California
OTHER
Responsible Party
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Kristina Rousso
Assistant Professor
Principal Investigators
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Kristina Rousso, AuD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Other Identifiers
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HS-19-00205
Identifier Type: -
Identifier Source: org_study_id