Lyric Self-replacement Clinical Investigation

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Phonak Lyric self-replacement procedure

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05349981

0700

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

57 participants in 1 patient group

Lyric self-replacement

Experimental group

Description:

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.

Treatment:

Device: Phonak Lyric self-replacement procedure