Hearing LossNCT05274165
Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology
A study testing Lyric Hearing Aid- Experimental Design and Lyric Hearing Aid- Commercially Available in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic. 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?
- Lyric Hearing Aid- Experimental Design and Lyric Hearing Aid- Commercially Available
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Mild to moderate hearing loss
- New hearing aid users with no previous hearing aid experience interested in trying Lyric devices
- Must meet Lyric candidacy (see exclusion criteria)
Who cannot join
- middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes
- radiation therapy to head or neck area
- participants who need regular MRI testing
- participants who regularly scuba dive or swim underwater
Trial locations and contacts
1 site in 1 country.
United States1 site
Sound Relief Hearing Center
Highlands Ranch, Colorado, 80129
About this study
Official title: Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate
Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic.
After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.
Read the detailed description
Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.
- Conditions
- Hearing Loss
- Being tested
- Lyric Hearing Aid- Experimental Design, Lyric Hearing Aid- Commercially Available
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyric Hearing Aid- Experimental DesignDevice
Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially AvailableDevice
Extended wear hearing aid that is currently available
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL. Receives: Device: Lyric Hearing Aid- Commercially Available |
| Group B | Experimental | Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant. Receives: Device: Lyric Hearing Aid- Experimental Design; Device: Lyric Hearing Aid- Commercially Available |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial to Success Rate
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
Measured: Day 30 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start29 Mar 2022
- Primary completion9 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sound Relief Tinnitus & Hearing Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274165
- Sponsor's protocol ID
- SRF-504
- Status last verified
- Jun 2023
- First submitted
- 1 Mar 2022
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate
- ClinicalTrials.gov ID
- NCT05274165
- Acronym / sponsor ID
- SRF-504
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Sound Relief Tinnitus & Hearing Center
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic.
After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.
Detailed description
Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Lyric Hearing Aid- Commercially AvailableParticipants will be fit with commercially available Lyric devices, which range from size XXS to XXL. |
| Group B | Experimental | Device: Lyric Hearing Aid- Experimental Design, Device: Lyric Hearing Aid- Commercially AvailableParticipants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate hearing loss
- New hearing aid users with no previous hearing aid experience interested in trying Lyric devices
- Must meet Lyric candidacy (see exclusion criteria)
Key exclusion criteria (4 listed)
- middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes
- radiation therapy to head or neck area
- participants who need regular MRI testing
- participants who regularly scuba dive or swim underwater
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 |
|---|---|---|
| Lyric Hearing Aid- Experimental DesignExtended wear hearing aid with a fitting modification that is currently not available | Device | Group B |
| Lyric Hearing Aid- Commercially AvailableExtended wear hearing aid that is currently available | Device | Group A, Group B |
Primary outcome
Trial to Success Rate
Time frame: Day 30 of study
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyric Hearing Aid- Experimental Design and Lyric Hearing Aid- Commercially Available in people with Hearing Loss, run by Sonova AG at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Trial to Success Rate (time frame: Day 30 of study). 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 28 Jun 2023.