Hearing LossNCT03902093
Morphology Effects of Extended Wear Hearing Instrument
A study testing Morphology changes with extended wear hearing aid in people with Hearing Loss, run by University of Southern California.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Morphology changes with extended wear hearing aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
About this study
Official title: Longitudinal Study of External Auditory Canal Morphology With Regards to Extended-wear Hearing Instrument
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Morphology changes with extended wear hearing aid
- Keywords
- hearing loss, hearing aid
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphology changes with extended wear hearing aidDiagnostic test
Possible changes in morphology due to wearing an extended wear hearing aid device will be assessed with imaging
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid | Experimental | 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. Receives: Diagnostic Test: Morphology changes with extended wear hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphology imaging
Imaging of the tissue at each appointment will be made
Measured: Complete study will take about six months per person
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Aug 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Why it stopped: Study is withdrawn due to no enrollment, due to COVID pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Rousso, University of Southern California
- Investigators
- Kristina Rousso, AuD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902093
- Sponsor's protocol ID
- HS-19-00205
- Status last verified
- Dec 2021
- First submitted
- 1 Apr 2019
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of External Auditory Canal Morphology With Regards to Extended-wear Hearing Instrument
- ClinicalTrials.gov ID
- NCT03902093
- Acronym / sponsor ID
- HS-19-00205
- Conditions
- Hearing Loss
- Keywords
- hearing loss, hearing aid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is withdrawn due to no enrollment, due to COVID pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid | Experimental | Diagnostic Test: Morphology changes with extended wear hearing aidActual 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphology changes with extended wear hearing aidPossible changes in morphology due to wearing an extended wear hearing aid device will be assessed with imaging | Diagnostic test | Hearing Aid |
Primary outcome
Morphology imaging
Time frame: Complete study will take about six months per person
Imaging of the tissue at each appointment will be made
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Rousso, AuD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing Morphology changes with extended wear hearing aid in people with Hearing Loss, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphology imaging (time frame: Complete study will take about six months per person). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.