Clinical trial NCT05349981: Lyric Self-replacement Clinical Investigation
Official title: Lyric Self-replacement Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: AccuData Solutions
First posted: 2022-04-27
Enrollment: 57
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self-controlled repeated measures study design with a single cohort, intended to mimic clinical use case.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in aided audiometric threshold testing between standard and experimental replacement procedures
timeFrame: Baseline, during intervention, immediately after intervention
measure: Change in aided speech-in-noise testing between standard and experimental replacement procedures
timeFrame: Baseline, during intervention, immediately after intervention
Secondary outcomes:
measure: Change in incidence of medical referrals secondary to device replacement procedure-related ear health outcome between standard and experimental replacement procedures
timeFrame: Through study completion, an average of 5 months
Other outcomes:
measure: Change in incidence of provider/clinical support needed across device replacement procedures
timeFrame: Through study completion, an average of 5 months
measure: Change in incidence of acoustic feedback across device replacement procedures
timeFrame: Baseline, during intervention, immediately after intervention
measure: Change in measured device position at replacement between standard and experimental replacement procedures
timeFrame: Baseline, during intervention, immediately after intervention
Locations:
city: San Francisco
country: United States
facility: San Francisco Audiology
state: California
city: New York
country: United States
facility: NYC Hearing Associates
state: New York
city: Greensboro
country: United States
facility: Aim Hearing and Audiology
state: North Carolina
city: Raleigh
country: United States
facility: ENT & Audiology Associates
state: North Carolina
city: The Woodlands
country: United States
facility: The Woodlands Hearing Center
state: Texas
city: Webster
country: United States
facility: Bay Area Audiology and Hearing Aids
state: Texas
city: Midlothian
country: United States
facility: Richmond Hearing Doctors
state: Virginia
city: Richmond
country: United States
facility: Richmond Hearing Doctors
state: Virginia
Study officials:
affiliation: Sonova USA Inc
name: Grace Gardner, AuD
role: STUDY_DIRECTOR
References: