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Lyric Self-replacement Clinical Investigation

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonak Lyric self-replacement procedure
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Francisco Audiology
  • NYC Hearing Associates
  • Aim Hearing and Audiology
  • ENT & Audiology Associates
  • The Woodlands Hearing Center
  • Bay Area Audiology and Hearing Aids
  • Richmond Hearing Doctors
  • Richmond Hearing Doctors

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lyric self-replacement

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2021
Last Updated
July 11, 2023
Sponsor
Sonova AG
Collaborators
AccuData Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT05349981
Brief Title
Lyric Self-replacement Clinical Investigation
Official Title
Lyric Self-replacement Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
AccuData Solutions

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lyric self-replacement
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Phonak Lyric self-replacement procedure
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in aided audiometric threshold testing between standard and experimental replacement procedures
Description
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.
Time Frame
Baseline, during intervention, immediately after intervention
Title
Change in aided speech-in-noise testing between standard and experimental replacement procedures
Description
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.
Time Frame
Baseline, during intervention, immediately after intervention
Secondary Outcome Measure Information:
Title
Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures
Description
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
Time Frame
Through study completion, an average of 5 months
Other Pre-specified Outcome Measures:
Title
Change in incidence of provider/clinical support needed across device replacement procedures
Description
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
Time Frame
Through study completion, an average of 5 months
Title
Change in incidence of acoustic feedback across device replacement procedures
Description
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
Time Frame
Baseline, during intervention, immediately after intervention
Title
Change in measured device position at replacement between standard and experimental replacement procedures
Description
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.
Time Frame
Baseline, during intervention, immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Gardner, AuD
Organizational Affiliation
Sonova USA Inc
Official's Role
Study Director
Facility Information:
Facility Name
San Francisco Audiology
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Facility Name
NYC Hearing Associates
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Aim Hearing and Audiology
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
ENT & Audiology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Woodlands Hearing Center
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Bay Area Audiology and Hearing Aids
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Richmond Hearing Doctors
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Richmond Hearing Doctors
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lyric Self-replacement Clinical Investigation

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