Hearing LossNCT04882800
Evaluation of Extended Wear Technology
A study testing Lyric extended wear hearing aid device A and Lyric extended wear hearing aid with fitting modification device B in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Lyric extended wear hearing aid device A and Lyric extended wear hearing aid with fitting modification device B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 15 Jun 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild, Moderate and Moderate Severe Hearing loss
- Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues
Who cannot join
- Participants who can only wear a size XXS (extra-extra small) extended wear device
- asymmetrical hearing loss
- other diagnosis that may cause hearing fluctuation
- inability to tolerate physical fit of Lyric devices
- inability to be seen for four lab visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Audiology Consultants
Narberth, Pennsylvania, 19072
About this study
Official title: Evaluation of Fitting Modification for Extended Wear Technology
Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.
Read the detailed description
A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.
- Conditions
- Hearing Loss
- Being tested
- Lyric extended wear hearing aid device A, Lyric extended wear hearing aid with fitting modification device B
- 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 extended wear hearing aid device ADevice
Current commercially available extended wear hearing aid
Lyric extended wear hearing aid with fitting modification device BDevice
Extended wear hearing aid with fitting modifications
| Study group | Role | What they receive |
|---|---|---|
| First Intervention | Experimental | Participants will be fit with currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study) Receives: Device: Lyric extended wear hearing aid device A; Device: Lyric extended wear hearing aid with fitting modification device B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Questionnaire of Comfort
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
Measured: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Subjective Ratings of Occlusion With Both Devices
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Measured: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start8 Apr 2021
- Primary completion31 May 2021
- Study completion15 Jun 2021
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be fit with commercially available extended wear hearing aid device A in the right ear and extended wear hearing aid with fitting modifications device B in the left ear for two weeks (first intervention); then fit with extended wear hearing aid with fitting modifications device B in the right ear and commercially available extended wear hearing aid device A in left ear for two weeks (second intervention). There will be no washout period.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Seitz-Paquette, AuD, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882800
- Sponsor's protocol ID
- SRF-72
- Status last verified
- Jul 2022
- First submitted
- 4 May 2021
- Last updated
- 14 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fitting Modification for Extended Wear Technology
- ClinicalTrials.gov ID
- NCT04882800
- Acronym / sponsor ID
- SRF-72
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Posted 14 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.
Detailed description
A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be fit with commercially available extended wear hearing aid device A in the right ear and extended wear hearing aid with fitting modifications device B in the left ear for two weeks (first intervention); then fit with extended wear hearing aid with fitting modifications device B in the right ear and commercially available extended wear hearing aid device A in left ear for two weeks (second intervention). There will be no washout period.
| Arm | Type | Receives |
|---|---|---|
| First Intervention | Experimental | Device: Lyric extended wear hearing aid device A, Device: Lyric extended wear hearing aid with fitting modification device BParticipants will be fit with currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild, Moderate and Moderate Severe Hearing loss
- Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues
Key exclusion criteria (5 listed)
- Participants who can only wear a size XXS (extra-extra small) extended wear device
- asymmetrical hearing loss
- other diagnosis that may cause hearing fluctuation
- inability to tolerate physical fit of Lyric devices
- inability to be seen for four lab visits
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 extended wear hearing aid device ACurrent commercially available extended wear hearing aid | Device | First Intervention |
| Lyric extended wear hearing aid with fitting modification device BExtended wear hearing aid with fitting modifications | Device | First Intervention |
Primary outcome
Subjective Questionnaire of Comfort
Time frame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
Subjective Ratings of Occlusion With Both Devices
Time frame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will not be shared
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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.
Kevin Seitz-Paquette, AuD principal investigator
Sonova AG
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 extended wear hearing aid device A and Lyric extended wear hearing aid with fitting modification device B 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 2 inclusion and 5 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 14 Dec 2022. 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 14 Dec 2022). 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?
Subjective Questionnaire of Comfort (time frame: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)). The study lists 2 primary outcomes in all. 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 14 Dec 2022.