Hearing LossNCT05349981
Lyric Self-replacement Clinical Investigation
A study testing Phonak Lyric self-replacement procedure in people with Hearing Loss, run by Sonova AG at 8 sites in United States.
Trial summary
This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phonak Lyric self-replacement procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Jul 2022to 9 Mar 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets requirements outlined on Lyric self-replacement candidacy form
- Current Lyric hearing instrument user with 3+ months of Lyric experience
- 22 years of age or older at the time of enrollment in the study
- Mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally)
- Good understanding (read/write/speak) of the English language
- Willingness to comply with all study requirements
Who cannot join
- Does not meet requirements outlined on Lyric self-replacement candidacy form
- Difficulty understanding/reading instructions when corrected for vision loss
- Impairments that would restrict participation in any of the evaluations
- Ear health conditions present at baseline that prevent immediate device replacement
- Conditions that would indicate the need for medical referral prior to hearing aid fitting according to local regulations
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Aim Hearing and Audiology
Greensboro, North Carolina, 27410
Richmond Hearing Doctors
Midlothian, Virginia, 23114
NYC Hearing Associates
New York, New York, 10018
ENT & Audiology Associates
Raleigh, North Carolina, 27612
Richmond Hearing Doctors
Richmond, Virginia, 23226
San Francisco Audiology
San Francisco, California, 94108
The Woodlands Hearing Center
The Woodlands, Texas, 77384
Bay Area Audiology and Hearing Aids
Webster, Texas, 77598
About this study
This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.
- Conditions
- Hearing Loss
- Being tested
- Phonak Lyric self-replacement procedure
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phonak Lyric self-replacement procedureDevice
The self-replacement procedure is an experimental procedure in which the Lyric user replaces the Lyric devices independently at every other device replacement, using dedicated candidacy, training, and management procedures, conducted by and at the discretion of his/her hearing care provider (HCP).
| Study group | Role | What they receive |
|---|---|---|
| Lyric self-replacement | Experimental | This cohort of experienced Lyric patients are required to meet the candidacy criteria to be eligible for the self-replacement procedure. They will also be required to demonstrate proficiency with the self-replacement procedure before proceeding with independent self-replacement. Receives: Device: Phonak Lyric self-replacement procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aided audiometric threshold testing between standard and experimental replacement procedures
Aided audiometric test measures: threshold testing. Thresholds will be measured in decibels Hearing Level (dBHL), with a range of -10 - 120 dBHL. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.
Measured: Baseline, during intervention, immediately after intervention
Change in aided speech-in-noise testing between standard and experimental replacement procedures
Aided audiometric test measures: speech-in-noise testing. Scores will be measured using signal-to-noise ratio loss, with scores ranging from 0 - 25.5. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.
Measured: Baseline, during intervention, immediately after intervention
Secondary outcomes (1)
Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures
Evaluation of incidence of medical referral secondary to device replacement, as determined necessary by the hearing care professional, and compared between the standard and experimental device replacement procedures
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start29 Jul 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AccuData Solutions
- Responsible party
- Sponsor
- Investigators
- Grace Gardner, AuD, Study director, Sonova USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349981
- Sponsor's protocol ID
- 0700
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2021
- Last updated
- 12 Jul 2023
- Results posted
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyric Self-replacement Clinical Investigation
- ClinicalTrials.gov ID
- NCT05349981
- Acronym / sponsor ID
- 0700
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- AccuData Solutions
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 27 Apr 2022 (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.
This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.
| Arm | Type | Receives |
|---|---|---|
| Lyric self-replacement | Experimental | Device: Phonak Lyric self-replacement procedureThis cohort of experienced Lyric patients are required to meet the candidacy criteria to be eligible for the self-replacement procedure. They will also be required to demonstrate proficiency with the self-replacement procedure before proceeding with independent self-replacement. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets requirements outlined on Lyric self-replacement candidacy form
- Current Lyric hearing instrument user with 3+ months of Lyric experience
- 22 years of age or older at the time of enrollment in the study
- Mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally)
- Good understanding (read/write/speak) of the English language
Key exclusion criteria (5 listed)
- Does not meet requirements outlined on Lyric self-replacement candidacy form
- Difficulty understanding/reading instructions when corrected for vision loss
- Impairments that would restrict participation in any of the evaluations
- Ear health conditions present at baseline that prevent immediate device replacement
- Conditions that would indicate the need for medical referral prior to hearing aid fitting according to local regulations
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 |
|---|---|---|
| Phonak Lyric self-replacement procedureThe self-replacement procedure is an experimental procedure in which the Lyric user replaces the Lyric devices independently at every other device replacement, using dedicated candidacy, training, and management procedures, conducted by and at the discretion of his/her hearing care provider (HCP). | Device | Lyric self-replacement |
Primary outcome
Change in aided audiometric threshold testing between standard and experimental replacement procedures
Time frame: Baseline, during intervention, immediately after intervention
Aided audiometric test measures: threshold testing. Thresholds will be measured in decibels Hearing Level (dBHL), with a range of -10 - 120 dBHL. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.
Change in aided speech-in-noise testing between standard and experimental replacement procedures
Time frame: Baseline, during intervention, immediately after intervention
Aided audiometric test measures: speech-in-noise testing. Scores will be measured using signal-to-noise ratio loss, with scores ranging from 0 - 25.5. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures.
1 secondary outcome
Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures
Time frame: Through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
Grace Gardner, AuD study director
Sonova USA Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonak Lyric self-replacement procedure in people with Hearing Loss, run by Sonova AG at 8 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 6 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in aided audiometric threshold testing between standard and experimental replacement procedures (time frame: Baseline, during intervention, immediately after intervention). 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 12 Jul 2023.