Status:
COMPLETED
Lyric Self-replacement Clinical Investigation
Lead Sponsor:
Sonova AG
Collaborating Sponsors:
AccuData Solutions
Conditions:
Hearing Loss
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.
Eligibility Criteria
Inclusion
- Meets requirements outlined on Lyric self-replacement candidacy form
- Current Lyric hearing instrument user with 3+ months of Lyric experience
- 22 years of age or older at the time of enrollment in the study
- Mild-to-moderately severe sensorineural hearing loss (bilaterally or unilaterally)
- Good understanding (read/write/speak) of the English language
- Willingness to comply with all study requirements
Exclusion
- Does not meet requirements outlined on Lyric self-replacement candidacy form
- Difficulty understanding/reading instructions when corrected for vision loss
- Impairments that would restrict participation in any of the evaluations
- Ear health conditions present at baseline that prevent immediate device replacement
- Conditions that would indicate the need for medical referral prior to hearing aid fitting according to local regulations
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05349981
Start Date
July 29 2022
End Date
March 9 2023
Last Update
July 12 2023
Active Locations (8)
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1
San Francisco Audiology
San Francisco, California, United States, 94108
2
NYC Hearing Associates
New York, New York, United States, 10018
3
Aim Hearing and Audiology
Greensboro, North Carolina, United States, 27410
4
ENT & Audiology Associates
Raleigh, North Carolina, United States, 27612