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OpenTrials
Completed

NCT Number: NCT01861704

Post-market Study to Capture Information Regarding Performance of Lyric2

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

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

InSound Medical

Newark, California, 94560, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lyric

Device

Extended wear hearing instrument

Lyric2

Device

Extended wear hearing instrument

Primary outcomes

  1. 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.

Secondary outcomes

  1. Device Comfort

    Time frame: During useful lifespan of device

  2. Gain, Speech Understanding and Sound Quality

    Time frame: During useful lifespan of device

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Phonak AG, Switzerland

Industry

Registry information

Official study title

Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 24, 2013
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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