Post-market Study to Capture Information Regarding Performance of Lyric2
1 other identifier
interventional
177
1 country
1
Brief Summary
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 24, 2013
CompletedResults Posted
Study results publicly available
May 19, 2014
CompletedMay 19, 2014
April 1, 2014
9 months
March 21, 2013
December 19, 2013
April 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Following device removal at the same appointment (Up to 24 hours after removal)
Secondary Outcomes (2)
Device Comfort
During useful lifespan of device
Gain, Speech Understanding and Sound Quality
During useful lifespan of device
Study Arms (2)
Lyric
ACTIVE COMPARATORSilver Lyric device
Lyric2
ACTIVE COMPARATORLyric2 (Barracuda) device
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
InSound Medical
Newark, California, 94560, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tanya Arbogast, Study Principal Investigator
- Organization
- InSound Medical, Newark, California
Study Officials
- PRINCIPAL INVESTIGATOR
Tanya Arbogast
Employee
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
May 24, 2013
Study Start
April 1, 2011
Primary Completion
January 1, 2012
Study Completion
April 1, 2012
Last Updated
May 19, 2014
Results First Posted
May 19, 2014
Record last verified: 2014-04