Trial Outcomes & Findings for Evaluation of Extended Wear Technology (NCT NCT04882800)
NCT ID: NCT04882800
Last Updated: 2022-12-14
Results Overview
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
COMPLETED
NA
15 participants
Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
2022-12-14
Participant Flow
Participant milestones
| Measure |
Intervention
Participants will be fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for two weeks (Day 1- Day 14 of study). They will then switch and be fit with device B in the right ear and device A in the left ear for two weeks (Day 15-Day 28 of study).
Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid
Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications
|
|---|---|
|
Device A Right Ear/Device B Left Ear
STARTED
|
15
|
|
Device A Right Ear/Device B Left Ear
COMPLETED
|
15
|
|
Device A Right Ear/Device B Left Ear
NOT COMPLETED
|
0
|
|
Device B Right Ear/Device A Left Ear
STARTED
|
15
|
|
Device B Right Ear/Device A Left Ear
COMPLETED
|
15
|
|
Device B Right Ear/Device A Left Ear
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=15 Participants
All participants who were fit with hearing aid device A in right ear and hearing aid device B in left ear Day 1 to Day 14 of study, and then fit with device B in the right ear and device A in the left ear Day 15 to Day 28 of study.
Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid
Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications
|
|---|---|
|
Age, Continuous
|
68 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)Population: All participants who were fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid device B in left ear Day 1- Day 14, and who were fit with extended wear hearing aid device B in right ear and commercially available hearing aid device A in left ear Day 15 to Day 28 of study.
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
Outcome measures
| Measure |
Intervention
n=30 Ears
Participants fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for two weeks,(Day 1 to Day 14 of study). They will then switch and be fit with device B in right ear and device A in left ear for two weeks (Day 15-Day 28 of study).
Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid
Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications
|
|---|---|
|
Subjective Questionnaire of Comfort
Comfort Rating of Device A
|
0 score on a scale
Interval 0.0 to 7.0
|
|
Subjective Questionnaire of Comfort
Comfort Rating of Device B (investigational device)
|
0 score on a scale
Interval 0.0 to 10.0
|
PRIMARY outcome
Timeframe: Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)Population: All participants who were fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid device B in left ear Day 1- Day 14, and who were fit with extended wear hearing aid device B in right ear and commercially available hearing aid device A in left ear Day 15 to Day 28 of study.
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Outcome measures
| Measure |
Intervention
n=30 Ears
Participants fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for two weeks,(Day 1 to Day 14 of study). They will then switch and be fit with device B in right ear and device A in left ear for two weeks (Day 15-Day 28 of study).
Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid
Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications
|
|---|---|
|
Subjective Ratings of Occlusion With Both Devices
Occlusion Rating with Device A
|
0 score on a scale
Interval 0.0 to 8.0
|
|
Subjective Ratings of Occlusion With Both Devices
Occlusion Rating with Device B (fitting modification)
|
0 score on a scale
Interval 0.0 to 10.0
|
Adverse Events
First Intervention (Device A in Right Ear and Device B in Left Ear)
Second Intervention (Device B in Right Ear and Device A in Left Ear)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place