Lyric Self-replacement Clinical Investigation

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Lyric self-replacement procedure

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • San Francisco Audiology
  • New York
    • New York, New York, United States, 10018
      • NYC Hearing Associates
  • North Carolina
    • Greensboro, North Carolina, United States, 27410
      • Aim Hearing and Audiology
    • Raleigh, North Carolina, United States, 27612
      • ENT & Audiology Associates
  • Texas
    • The Woodlands, Texas, United States, 77384
      • The Woodlands Hearing Center
    • Webster, Texas, United States, 77598
      • Bay Area Audiology and Hearing Aids
  • Virginia
    • Midlothian, Virginia, United States, 23114
      • Richmond Hearing Doctors
    • Richmond, Virginia, United States, 23226
      • Richmond Hearing Doctors

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: AccuData Solutions
• Investigators: Study Director: Grace Gardner, AuD, Sonova USA Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 0700 (Sponsor)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No