Lyric Self-replacement Clinical Investigation
- Conditions
- Hearing Loss
- Interventions
- Device: Phonak Lyric self-replacement procedure
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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
- 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
- Arm && Interventions
Group Intervention Description Lyric self-replacement Phonak Lyric self-replacement procedure 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.
- 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)
Aim Hearing and Audiology
🇺🇸Greensboro, North Carolina, United States
San Francisco Audiology
🇺🇸San Francisco, California, United States
NYC Hearing Associates
🇺🇸New York, New York, United States
Bay Area Audiology and Hearing Aids
🇺🇸Webster, Texas, United States
ENT & Audiology Associates
🇺🇸Raleigh, North Carolina, United States
The Woodlands Hearing Center
🇺🇸The Woodlands, Texas, United States
Richmond Hearing Doctors
🇺🇸Richmond, Virginia, United States