Trial Outcomes & Findings for Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology (NCT NCT05274165)
NCT ID: NCT05274165
Last Updated: 2023-06-28
Results Overview
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Day 30 of study
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Group A
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
Group B
Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
Lyric Hearing Aid- Experimental Design: Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Group A
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
Group B
Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
Lyric Hearing Aid- Experimental Design: Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=12 Participants
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
Group B
n=13 Participants
Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
Lyric Hearing Aid- Experimental Design: Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
62 years
n=12 Participants
|
66 years
n=13 Participants
|
64 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=12 Participants
|
7 Participants
n=13 Participants
|
10 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=12 Participants
|
6 Participants
n=13 Participants
|
15 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
13 participants
n=13 Participants
|
25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: Day 30 of studyPopulation: All participants that were fit with extended wear hearing devices
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
Outcome measures
| Measure |
Group A
n=9 Participants
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
Group B
n=10 Participants
Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
Lyric Hearing Aid- Experimental Design: Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
|
|---|---|---|
|
Trial to Success Rate
|
2 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=12 participants at risk
Participants for whom only the commercially available Lyric sizes were available. The clinician was limited to choosing the best fit among the commercially available sizes only. This group includes participants who started and ended the trial with only commercially available sizes of Lyric.
|
Group B
n=13 participants at risk
Participants for whom the commercially available sizes and the experimental sizes of Lyric were available. The clinician was able to choose the best fit from all sizes. This group includes participants who may have started the trial with an experimental device but ended with a commercially available size, and vice-versa, depending on the wearing comfort and the discretion of the clinician.
|
|---|---|---|
|
Ear and labyrinth disorders
discomfort
|
8.3%
1/12 • Number of events 1 • 30 days
|
7.7%
1/13 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place