Lyric Self-replacement Clinical Investigation

July 11, 2023 updated by: Sonova AG
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in aided audiometric threshold testing between standard and experimental replacement procedures
Time Frame: 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.
Baseline, during intervention, immediately after intervention
Change in aided speech-in-noise testing between standard and experimental replacement procedures
Time Frame: 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.
Baseline, during intervention, immediately after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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
Through study completion, an average of 5 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in incidence of provider/clinical support needed across device replacement procedures
Time Frame: Through study completion, an average of 5 months
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
Time Frame: Baseline, during intervention, immediately after intervention
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
Time Frame: Baseline, during intervention, immediately after intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sonova AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AccuData Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Grace Gardner, AuD, Sonova USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0700 (Other Identifier: 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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