Lyric Self-replacement Clinical Investigation

Study Overview
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Brief Summary
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This study is designed to investigate the effectiveness and safety of the Phonak Lyric self-replacement procedure, as compared to the HCP-replacement procedure.

Official Title
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Lyric Self-replacement Clinical Investigation

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Phonak Lyric self-replacement procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lyric self-replacement<br>This cohort of experienced Lyric patients are required to meet the candidacy criteria to be eligible for the self-replacement procedure. They will also be required to demonstrate proficiency with the self-replacement procedure before proceeding with independent self-replacement. | Device: Phonak Lyric self-replacement procedure<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aided audiometric threshold testing between standard and experimental replacement procedures | Aided audiometric test measures: threshold testing. Thresholds will be measured in decibels Hearing Level (dBHL), with a range of -10 - 120 dBHL. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures. | Baseline, during intervention, immediately after intervention | 
| Change in aided speech-in-noise testing between standard and experimental replacement procedures | Aided audiometric test measures: speech-in-noise testing. Scores will be measured using signal-to-noise ratio loss, with scores ranging from 0 - 25.5. Lower scores indicate better performance. Change in scores will be assessed between standard and experimental replacement procedures. | Baseline, during intervention, immediately after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures | Evaluation of incidence of medical referral secondary to device replacement, as determined necessary by the hearing care professional, and compared between the standard and experimental device replacement procedures | Through study completion, an average of 5 months |