Post-market Study to Capture Information Regarding Performance of Lyric2

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861704
• Other study ID #: 000.000.004.858
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: April 16, 2014
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: Phonak AG, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• Lyric
Extended wear hearing instrument
• Lyric2
Extended wear hearing instrument

Locations

Country	Name	City	State
United States	InSound Medical	Newark	California

Sponsors (1)

Lead Sponsor	Collaborator
Phonak AG, Switzerland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Device Comfort		During useful lifespan of device	No
Secondary	Gain, Speech Understanding and Sound Quality		During useful lifespan of device	No