NCT06169683

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

December 5, 2023

Last Update Submit

December 5, 2023

Conditions

Hearing Loss

Keywords

hearing loss

Outcome Measures

Primary Outcomes (1)

  • Aided Audiometric Testing

    From enrollment to the end of the study period, approximately one month.

Study Arms (1)

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

Lyric4DEVICE

Lyric4 Hearing instrument use

Experienced Lyric Users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sonova Silicon Valley

Fremont, California, 94538, United States

Location

Triangle Hearing Services

Cary, North Carolina, 27513, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

November 10, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)