Study Stopped
Study is withdrawn due to no enrollment, due to COVID pandemic.
Morphology Effects of Extended Wear Hearing Instrument
Longitudinal Study of External Auditory Canal Morphology With Regards to Extended-wear Hearing Instrument
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedDecember 15, 2021
December 1, 2021
6 months
April 1, 2019
December 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphology imaging
Imaging of the tissue at each appointment will be made
Complete study will take about six months per person
Study Arms (1)
Hearing Aid
EXPERIMENTALActual 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.
Interventions
Possible changes in morphology due to wearing an extended wear hearing aid device will be assessed with imaging
Eligibility Criteria
You may qualify if:
- Adult patients in the USC Otolaryngology Clinic who are determined to be candidates for a Lyric extended wear hearing aid device by their treating Audiologist (in general people with mild to moderate hearing loss may be eligible).
You may not qualify if:
- Patients in the USC Clinic who are determined by the Audiologist not to be good candidates for the Hearing aid extended wear device (in general, people with severe hearing loss are not eligible).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina Rousso, AuD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
August 1, 2022
Primary Completion
February 1, 2023
Study Completion
June 1, 2023
Last Updated
December 15, 2021
Record last verified: 2021-12