Lyric Self-replacement Clinical Investigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-29

Study Completion Date

2023-03-09

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.

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Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lyric self-replacement

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.

Group Type EXPERIMENTAL

Phonak Lyric self-replacement procedure

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes