Hearing Loss
Conditions
Brief summary
Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.
Detailed description
A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.
Interventions
DEVICELyric extended wear hearing aid device A
Current commercially available extended wear hearing aid
DEVICELyric extended wear hearing aid with fitting modification device B
Extended wear hearing aid with fitting modifications
Sponsors
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Participants will not know which device is in each ear, only that they are being fit with Lyric devices.
Intervention model description
Participants will be fit with commercially available extended wear hearing aid device A in the right ear and extended wear hearing aid with fitting modifications device B in the left ear for two weeks (first intervention); then fit with extended wear hearing aid with fitting modifications device B in the right ear and commercially available extended wear hearing aid device A in left ear for two weeks (second intervention). There will be no washout period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Mild, Moderate and Moderate Severe Hearing loss * Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues
Exclusion criteria
* Participants who can only wear a size XXS (extra-extra small) extended wear device * asymmetrical hearing loss * other diagnosis that may cause hearing fluctuation * inability to tolerate physical fit of Lyric devices * inability to be seen for four lab visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Questionnaire of Comfort | 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) | 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. |
| Subjective Ratings of Occlusion With Both Devices | 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) | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study 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 | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 68 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Subjective Questionnaire of Comfort
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Subjective Questionnaire of Comfort | Comfort Rating of Device A | 0 score on a scale |
| Intervention | Subjective Questionnaire of Comfort | Comfort Rating of Device B (investigational device) | 0 score on a scale |
Primary
Subjective Ratings of Occlusion With Both Devices
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)
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Subjective Ratings of Occlusion With Both Devices | Occlusion Rating with Device A | 0 score on a scale |
| Intervention | Subjective Ratings of Occlusion With Both Devices | Occlusion Rating with Device B (fitting modification) | 0 score on a scale |