Hearing LossNCT06169683
Lyric4 Outcomes Evaluation
A study testing Lyric4 in people with Hearing Loss, run by Sonova AG at 2 sites in United States.
Trial summary
The goal of this clinical investigation is to obtain feedback on Lyric4 device updates within a cohort of experienced adult Lyric hearing instrument users. The main question it aims to answer is: Do device updates cause a change in Lyric patient experience? Participants will be asked to complete questionnaires about… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Lyric4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2023to Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experience with Lyric hearing instruments
- Willingness to travel to the study site and complete study procedures
- Adults, age 18 or older
- Fluency with English (written/spoken)
Who cannot join
- No Lyric hearing instrument experience
- Ear health issues preventing Lyric fitting or requiring medical clearance prior to fitting
- Difficulty reading when corrected for vision loss
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Triangle Hearing Services
Cary, North Carolina, 27513
Sonova Silicon Valley
Fremont, California, 94538
About this study
Official title: Evaluation of Daily- and Extended-wear Hearing Instruments
The goal of this clinical investigation is to obtain feedback on Lyric4 device updates within a cohort of experienced adult Lyric hearing instrument users. The main question it aims to answer is:
- Do device updates cause a change in Lyric patient experience?
Participants will be asked to complete questionnaires about their past experience with Lyric, as well as their experience with Lyric during the study period. They will also be asked to undergo aided audiometric testing with Lyric devices.
- Conditions
- Hearing Loss
- Being tested
- Lyric4
- Keywords
- hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyric4Device
Lyric4 Hearing instrument use
| Study group | Role | What they receive |
|---|---|---|
| Experienced Lyric Users | Experimental | This cohort of participants is required to have Lyric hearing instrument experience, and they will be asked to wear Lyric for the duration of the study period and report on their experience. Receives: Device: Lyric4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aided Audiometric Testing
Measured: From enrollment to the end of the study period, approximately one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start10 Nov 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169683
- Sponsor's protocol ID
- SRF-6569
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Daily- and Extended-wear Hearing Instruments
- ClinicalTrials.gov ID
- NCT06169683
- Acronym / sponsor ID
- SRF-6569
- Conditions
- Hearing Loss
- Keywords
- hearing loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 13 Dec 2023 (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 goal of this clinical investigation is to obtain feedback on Lyric4 device updates within a cohort of experienced adult Lyric hearing instrument users. The main question it aims to answer is:
- Do device updates cause a change in Lyric patient experience?
Participants will be asked to complete questionnaires about their past experience with Lyric, as well as their experience with Lyric during the study period. They will also be asked to undergo aided audiometric testing with Lyric devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experienced Lyric Users | Experimental | Device: Lyric4This cohort of participants is required to have Lyric hearing instrument experience, and they will be asked to wear Lyric for the duration of the study period and report on their experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experience with Lyric hearing instruments
- Willingness to travel to the study site and complete study procedures
- Adults, age 18 or older
- Fluency with English (written/spoken)
Key exclusion criteria (3 listed)
- No Lyric hearing instrument experience
- Ear health issues preventing Lyric fitting or requiring medical clearance prior to fitting
- Difficulty reading when corrected for vision loss
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 |
|---|---|---|
| Lyric4Lyric4 Hearing instrument use | Device | Experienced Lyric Users |
Primary outcome
Aided Audiometric Testing
Time frame: From enrollment to the end of the study period, approximately one month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyric4 in people with Hearing Loss, run by Sonova AG at 2 sites in United States.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Aided Audiometric Testing (time frame: From enrollment to the end of the study period, approximately one month.). 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 13 Dec 2023.