Lyric Self-replacement Clinical Investigation

Not Applicable

Completed

• Conditions: Hearing Loss

• Registration Number: NCT05349981
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-27
• Study Start: 2022-07-29
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in aided audiometric threshold testing between standard and experimental replacement procedures	Baseline, during intervention, immediately after intervention	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.
Change in aided speech-in-noise testing between standard and experimental replacement procedures	Baseline, during intervention, immediately after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures	Through study completion, an average of 5 months	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

Trial Locations

Locations (7)

San Francisco Audiology; 🇺🇸 San Francisco, California, United States

NYC Hearing Associates; 🇺🇸 New York, New York, United States

Aim Hearing and Audiology; 🇺🇸 Greensboro, North Carolina, United States

ENT & Audiology Associates; 🇺🇸 Raleigh, North Carolina, United States

The Woodlands Hearing Center; 🇺🇸 The Woodlands, Texas, United States

Bay Area Audiology and Hearing Aids; 🇺🇸 Webster, Texas, United States

Richmond Hearing Doctors; 🇺🇸 Richmond, Virginia, United States