Post-market Study to Capture Information Regarding Performance of Lyric2

NCT ID: NCT01861704

Last Updated: 2014-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Lyric

Silver Lyric device

Group Type ACTIVE_COMPARATOR

Lyric

Intervention Type DEVICE

Extended wear hearing instrument

Lyric2

Lyric2 (Barracuda) device

Group Type ACTIVE_COMPARATOR

Lyric2

Intervention Type DEVICE

Extended wear hearing instrument

Interventions

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Lyric

Extended wear hearing instrument

Intervention Type DEVICE

Lyric2

Extended wear hearing instrument

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phonak AG, Switzerland

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanya Arbogast

Role: PRINCIPAL_INVESTIGATOR

Employee

Locations

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InSound Medical

Newark, California, United States

Site Status

Countries

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United States

Other Identifiers

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000.000.004.858

Identifier Type: -

Identifier Source: org_study_id

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