Lyric4 Outcomes Evaluation | NCT06169683

Studies
Lyric4 Outcomes Evaluation

NCT06169683

Sponsor

Sonova AG

Status

Unknown status

Last Update Posted

Dec 13, 2023Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Hearing Loss

Interventions

Lyric4

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2023Actual

Primary Completion Date

Jan 2024Estimated

Completion Date

Jan 2024Estimated

First Submitted Date

Dec 5, 2023

First Submission Date that Met QC Criteria

Dec 5, 2023

First Posted Date

Dec 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2023

Last Update Posted Date

Dec 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical investigation is to obtain feedback on Lyric4 device updates within a cohort of experienced adult Lyric hearing instrument users. The main question it aims to answer is:

• Do device updates cause a change in Lyric patient experience?

Participants will be asked to complete questionnaires about their past experience with Lyric, as well as their experience with Lyric during the study period. They will also be asked to undergo aided audiometric testing with Lyric devices.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experienced Lyric Users	Experimental	This cohort of participants is required to have Lyric hearing instrument experience, and they will be asked to wear Lyric for the duration of the study period and report on their experience.	Device: Lyric4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lyric4	Device	Lyric4 Hearing instrument use	Experienced Lyric Users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aided Audiometric Testing		From enrollment to the end of the study period, approximately one month.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Experience with Lyric hearing instruments
Willingness to travel to the study site and complete study procedures
Adults, age 18 or older
Fluency with English (written/spoken)

Exclusion Criteria:

No Lyric hearing instrument experience
Ear health issues preventing Lyric fitting or requiring medical clearance prior to fitting
Difficulty reading when corrected for vision loss

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sonova Silicon Valley		Fremont	California	94538	United States
Triangle Hearing Services

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided