Hearing LossNCT01861704
Post-market Study to Capture Information Regarding Performance of Lyric2
A study testing Lyric and Lyric2 in people with Hearing Loss, run by Phonak AG, Switzerland at 1 site in United States.
Trial summary
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety. 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 and Lyric2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2012
- 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
- Aged 18-90 years at the time of enrollment in the study
- Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear
- Fluent in English
- Willingness to comply with all study requirements
Who cannot join
- Scuba dives or sky dives
- Underwater swimming or dives into the water
- Handicaps that would restrict participation in all the evaluations
- Hearing loss of neural or central origin
- Unrealistic expectations regarding benefits and limitations inherent in the devices
- Chemotherapy within the last six months
Show all 16Show fewer
- Compromised immune system
- Radiation to head or neck
- Perforated tympanic membrane
- History of cholesteatoma
- Active outer or middle ear pathology
- High levels of anticoagulant therapy
- Insulin-dependent and/or uncontrolled diabetes
- Contact dermatitis
- Bleeding disorder
- Unwillingness or inability to comply with all study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
Read the detailed description
Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.
- Conditions
- Hearing Loss
- Being tested
- Lyric, Lyric2
- Keywords
- Mild to moderate 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.
LyricDevice
Extended wear hearing instrument
Lyric2Device
Extended wear hearing instrument
| Study group | Role | What they receive |
|---|---|---|
| Lyric | Active comparator | Silver Lyric device Receives: Device: Lyric |
| Lyric2 | Active comparator | Lyric2 (Barracuda) device Receives: Device: Lyric2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Refit Upon Device Removal
Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.
Measured: Following device removal at the same appointment (Up to 24 hours after removal)
Secondary outcomes (2)
Device Comfort
Measured: During useful lifespan of device
Gain, Speech Understanding and Sound Quality
Measured: During useful lifespan of device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionApr 2012
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phonak AG, Switzerland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tanya Arbogast, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861704
- Sponsor's protocol ID
- 000.000.004.858
- Status last verified
- Apr 2014
- First submitted
- 21 Mar 2013
- Last updated
- 19 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric
- ClinicalTrials.gov ID
- NCT01861704
- Acronym / sponsor ID
- 000.000.004.858
- Conditions
- Hearing Loss
- Keywords
- Mild to moderate hearing loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Phonak AG, SwitzerlandIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Posted 19 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
Detailed description
Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyric | Active comparator | Device: LyricSilver Lyric device |
| Lyric2 | Active comparator | Device: Lyric2Lyric2 (Barracuda) device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-90 years at the time of enrollment in the study
- Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear
- Fluent in English
- Willingness to comply with all study requirements
Key exclusion criteria (16 listed)
- Scuba dives or sky dives
- Underwater swimming or dives into the water
- Handicaps that would restrict participation in all the evaluations
- Hearing loss of neural or central origin
- Unrealistic expectations regarding benefits and limitations inherent in the devices
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 |
|---|---|---|
| LyricExtended wear hearing instrument | Device | Lyric |
| Lyric2Extended wear hearing instrument | Device | Lyric2 |
Primary outcome
Immediate Refit Upon Device Removal
Time frame: Following device removal at the same appointment (Up to 24 hours after removal)
Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.
2 secondary outcomes
Device Comfort
Time frame: During useful lifespan of device
Gain, Speech Understanding and Sound Quality
Time frame: During useful lifespan of device
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tanya Arbogast principal investigator
Employee
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 and Lyric2 in people with Hearing Loss, run by Phonak AG, Switzerland 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 4 inclusion and 16 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 19 May 2014. 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 19 May 2014). 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?
Immediate Refit Upon Device Removal (time frame: Following device removal at the same appointment (Up to 24 hours after removal)). 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 19 May 2014.