Lyric Self-replacement Clinical Investigation

NCT05349981 | Completed FDA Device

• 1 other identifier: 0700
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 8

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Other Outcomes (3)

• Change in incidence of provider/clinical support needed across device replacement procedures

  Through study completion, an average of 5 months

• Change in incidence of acoustic feedback across device replacement procedures

  Baseline, during intervention, immediately after intervention

• Change in measured device position at replacement between standard and experimental replacement procedures

  Baseline, during intervention, immediately after intervention

Study Arms (1)

Lyric self-replacement

EXPERIMENTAL

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

Interventions

Phonak Lyric self-replacement procedure DEVICE

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).

Lyric self-replacement

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets requirements outlined on Lyric self-replacement candidacy form
• Current Lyric hearing instrument user with 3+ months of Lyric experience
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead
• AccuData Solutions: collaborator

Study Sites (8)

San Francisco Audiology

San Francisco, California, 94108, United States

Location

NYC Hearing Associates

New York, New York, 10018, United States

Location

Aim Hearing and Audiology

Greensboro, North Carolina, 27410, United States

Location

ENT & Audiology Associates

Raleigh, North Carolina, 27612, United States

Location

The Woodlands Hearing Center

The Woodlands, Texas, 77384, United States

Location

Bay Area Audiology and Hearing Aids

Webster, Texas, 77598, United States

Location

Richmond Hearing Doctors

Midlothian, Virginia, 23114, United States

Location

Richmond Hearing Doctors

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Grace Gardner, AuD

  Sonova USA Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: April 27, 2022
• Study Start: July 29, 2022
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)