Lyric Self-replacement Clinical Investigation
NCT05349981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2023-07-12
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.
Conditions
Interventions
- DEVICE
-
Phonak Lyric self-replacement procedure
The self-replacement procedure is an experimental procedure in which the Lyric user replaces the Lyric devices independently at every other device replacement, using dedicated candidacy, training, and management procedures, conducted by and at the discretion of his/her hearing care provider (HCP).
Sponsors & Collaborators
-
AccuData Solutions
collaborator UNKNOWN -
Sonova AG
lead INDUSTRY
Principal Investigators
-
Grace Gardner, AuD · Sonova USA Inc
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-07-29
- Primary Completion
- 2023-03-09
- Completion
- 2023-03-09
- FDA Device
- Yes
Countries
- United States
Study Locations
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