Post-market Study to Capture Information Regarding Performance of Lyric2

Phonak

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Lyric

Device: Lyric2

Study type

Interventional

Funder types

Industry

Identifiers

000.000.004.858

Details and patient eligibility

About

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

Full description

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

Enrollment

177 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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