Post-market Study to Capture Information Regarding Performance of Lyric2

April 16, 2014 updated by: Phonak AG, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newark, California, United States, 94560
        • InSound Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Unwillingness or inability to comply with all study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lyric
Silver Lyric device
Device: Lyric
Extended wear hearing instrument
Active Comparator: Lyric2
Lyric2 (Barracuda) device
Device: Lyric2
Extended wear hearing instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Following device removal at the same appointment (Up to 24 hours after removal)

Secondary Outcome Measures

Outcome Measure
Time Frame
Device Comfort
Time Frame: During useful lifespan of device
During useful lifespan of device
Gain, Speech Understanding and Sound Quality
Time Frame: During useful lifespan of device
During useful lifespan of device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phonak AG, Switzerland

Investigators

  • Principal Investigator: Tanya Arbogast, Employee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000.000.004.858

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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