Lyric Self-replacement Clinical Investigation

Hearing Loss Clinical Trial

Official title:

Lyric Self-replacement Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349981
• Other study ID #: 0700
• Status: Completed
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: March 9, 2023

Study information

• Verified date: July 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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).

Locations

Country	Name	City	State
United States	Aim Hearing and Audiology	Greensboro	North Carolina
United States	Richmond Hearing Doctors	Midlothian	Virginia
United States	NYC Hearing Associates	New York	New York
United States	ENT & Audiology Associates	Raleigh	North Carolina
United States	Richmond Hearing Doctors	Richmond	Virginia
United States	San Francisco Audiology	San Francisco	California
United States	The Woodlands Hearing Center	The Woodlands	Texas
United States	Bay Area Audiology and Hearing Aids	Webster	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	AccuData Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in incidence of provider/clinical support needed across device replacement procedures	Evaluation of incidence of provider/clinical support needed between device replacements, as recorded by study staff, and compared between time periods associated with the standard and experimental device replacement procedures	Through study completion, an average of 5 months
Other	Change in incidence of acoustic feedback across device replacement procedures	Evaluation of incidence of acoustic feedback secondary to device replacement, as subjectively reported by the end user, and compared between the standard and experimental device replacement procedures	Baseline, during intervention, immediately after intervention
Other	Change in measured device position at replacement between standard and experimental replacement procedures	Achieved insertion depth of device, as measured by the hearing care professional using the dedicated fitting tool, and compared between the standard and experimental fitting procedures.	Baseline, during intervention, immediately after intervention
Primary	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
Primary	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	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