Trial Outcomes & Findings for Adhear Bone Conduction System (NCT NCT03533686)
NCT ID: NCT03533686
Last Updated: 2023-08-08
Results Overview
Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Hearing thresholds were measured in hertz.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Day 1
Results posted on
2023-08-08
Participant Flow
Participant milestones
| Measure |
Single-Sided Deafness Adult (Aim1) Group
Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Conductive Hearing Loss Adult (Aim 2) Group
Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Adhear Followed by BAHA (Aim 3) Group
Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the Adhear system for 2 weeks (plus up to 90 days) followed by bone anchored hearing aid (BAHA) for another 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband
|
BAHA Followed by Adhear (Aim 3) Group
Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the BAHA system for 2 weeks (plus up to 90 days) followed by Adhear for another 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband
|
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group
Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group
Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
18
|
15
|
17
|
4
|
|
Overall Study
Received Intervention
|
8
|
3
|
18
|
12
|
14
|
4
|
|
Overall Study
COMPLETED
|
8
|
2
|
18
|
10
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
5
|
7
|
1
|
Reasons for withdrawal
| Measure |
Single-Sided Deafness Adult (Aim1) Group
Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Conductive Hearing Loss Adult (Aim 2) Group
Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Adhear Followed by BAHA (Aim 3) Group
Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the Adhear system for 2 weeks (plus up to 90 days) followed by bone anchored hearing aid (BAHA) for another 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband
|
BAHA Followed by Adhear (Aim 3) Group
Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the BAHA system for 2 weeks (plus up to 90 days) followed by Adhear for another 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband
|
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group
Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group
Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
3
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Screen Failure
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Adhear Bone Conduction System
Baseline characteristics by cohort
| Measure |
Single-Sided Deafness Adult (Aim1) Group
n=9 Participants
Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Conductive Hearing Loss Adult (Aim 2) Group
n=3 Participants
Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Adhear Followed by BAHA (Aim 3) Group
n=18 Participants
Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the Adhear system for 3 weeks (plus up to 90 days) followed by bone anchored hearing aid (BAHA) for another 3 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband
|
BAHA Followed by Adhear (Aim 3) Group
n=15 Participants
Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the BAHA system for 3 weeks (plus up to 90 days) followed by Adhear for another 3 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
Bone anchored hearing aid (BAHA): Non-invasive bone conduction hearing device using a headband
|
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group
n=17 Participants
Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group
n=4 Participants
Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days).
Adhear Bone Conduction System: Non-invasive bone conduction hearing device using adhesive
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Hearing thresholds were measured in hertz.
Outcome measures
| Measure |
BAHA Implant
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 250
|
36.25 hertz
Standard Deviation 7.44
|
35.63 hertz
Standard Deviation 10.16
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 500
|
28.13 hertz
Standard Deviation 6.51
|
37.50 hertz
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 1000
|
20 hertz
Standard Deviation 2.67
|
30.63 hertz
Standard Deviation 6.23
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 2000
|
23.13 hertz
Standard Deviation 2.59
|
35.00 hertz
Standard Deviation 8.45
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 3000
|
27.5 hertz
Standard Deviation 5.35
|
44.38 hertz
Standard Deviation 4.17
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 4000
|
33.13 hertz
Standard Deviation 5.94
|
51.25 hertz
Standard Deviation 6.94
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 6000
|
31.88 hertz
Standard Deviation 6.51
|
56.88 hertz
Standard Deviation 5.30
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 8000
|
40 hertz
Standard Deviation 11.65
|
56.88 hertz
Standard Deviation 7.53
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Hearing thresholds were measured in hertz.
Outcome measures
| Measure |
BAHA Implant
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 250
|
17.5 hertz
Standard Deviation 3.54
|
27.5 hertz
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 500
|
12.5 hertz
Standard Deviation 10.61
|
20 hertz
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 1000
|
22.50 hertz
Standard Deviation 3.54
|
22.5 hertz
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 2000
|
27.5 hertz
Standard Deviation 3.54
|
30 hertz
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 3000
|
35 hertz
Standard Deviation 0
|
40 hertz
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 4000
|
37.5 hertz
Standard Deviation 10.61
|
55 hertz
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 6000
|
40 hertz
Standard Deviation 14.14
|
50 hertz
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 8000
|
47.5 hertz
Standard Deviation 3.54
|
55 hertz
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz.
Outcome measures
| Measure |
BAHA Implant
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 250
|
37.5 hertz
Standard Deviation 6.78
|
31.88 hertz
Standard Deviation 11.27
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 500
|
31.75 hertz
Standard Deviation 9.11
|
32.13 hertz
Standard Deviation 9.63
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 1000
|
24.38 hertz
Standard Deviation 7.01
|
28.38 hertz
Standard Deviation 4.98
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 2000
|
28.88 hertz
Standard Deviation 6.60
|
31.75 hertz
Standard Deviation 7.40
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 3000
|
35.38 hertz
Standard Deviation 6.91
|
42.88 hertz
Standard Deviation 4.82
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 4000
|
45.25 hertz
Standard Deviation 6.36
|
50.75 hertz
Standard Deviation 7.80
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 6000
|
46.5 hertz
Standard Deviation 10.73
|
53.88 hertz
Standard Deviation 7.51
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Single Sided Deafness
Frequency 8000
|
50.50 hertz
Standard Deviation 6.37
|
54.25 hertz
Standard Deviation 7.21
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz.
Outcome measures
| Measure |
BAHA Implant
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 250
|
17.5 hertz
Standard Deviation 3.54
|
22.5 hertz
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 500
|
12.5 hertz
Standard Deviation 10.61
|
25 hertz
Standard Deviation 14.14
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 1000
|
22.5 hertz
Standard Deviation 3.54
|
17.5 hertz
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 2000
|
27.5 hertz
Standard Deviation 3.54
|
35 hertz
Standard Deviation 14.14
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 3000
|
35 hertz
Standard Deviation 0
|
47.5 hertz
Standard Deviation 10.61
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 4000
|
37.50 hertz
Standard Deviation 10.61
|
55 hertz
Standard Deviation 14.14
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 6000
|
40 hertz
Standard Deviation 14.14
|
50 hertz
Standard Deviation 14.14
|
—
|
—
|
—
|
—
|
|
Aided Hearing Thresholds for Conductive Hearing Loss
Frequency 8000
|
47.5 hertz
Standard Deviation 3.54
|
57.5 hertz
Standard Deviation 10.61
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14 of the interventionPopulation: This outcome measure corresponds to Aim 3, Aim 3a, and Aim 3b. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit. Insufficient sample collected for participants and thus the data could not be analyzed for arms BAHA Bilateral Conductive Hearing Loss Prior BAI Use and Adhear Bilateral Conducive Hearing Loss Prior BAI Use.
Aided-hearing thresholds represent the softest sound that the participant can hear inside the audiometric test booth when using a hearing device. Aided hearing thresholds were measured using a traditional bone conduction device on a softband and the Adhear device in the test booth on day 14. Hearing thresholds were measured in hertz.
Outcome measures
| Measure |
BAHA Implant
n=33 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=33 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
n=17 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
n=17 Participants
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
n=1 Participants
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
n=1 Participants
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Hearing Thresholds
Frequency 250
|
19.43 hertz
Standard Deviation 6.44
|
28 hertz
Standard Deviation 9.76
|
24.17 hertz
Standard Deviation 2.04
|
24 hertz
Standard Deviation 7.41
|
15 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
30 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
|
Aided Hearing Thresholds
Frequency 500
|
15.64 hertz
Standard Deviation 6.54
|
24.57 hertz
Standard Deviation 7.51
|
22.50 hertz
Standard Deviation 5.24
|
21 hertz
Standard Deviation 6.52
|
10 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
15 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
|
Aided Hearing Thresholds
Frequency 1000
|
13.64 hertz
Standard Deviation 7.47
|
21.43 hertz
Standard Deviation 4.97
|
22.50 hertz
Standard Deviation 8.22
|
22 hertz
Standard Deviation 6.71
|
15 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
20 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
|
Aided Hearing Thresholds
Frequency 2000
|
18.86 hertz
Standard Deviation 5.17
|
24.86 hertz
Standard Deviation 6.71
|
22.50 hertz
Standard Deviation 4.18
|
27 hertz
Standard Deviation 8.36
|
15 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
20 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
|
Aided Hearing Thresholds
Frequency 3000
|
24.43 hertz
Standard Deviation 6.85
|
34 hertz
Standard Deviation 8.23
|
30 hertz
Standard Deviation 6.32
|
28 hertz
Standard Deviation 12.54
|
30 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
40 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
|
Aided Hearing Thresholds
Frequency 4000
|
26.50 hertz
Standard Deviation 5.81
|
39.71 hertz
Standard Deviation 8.48
|
30 hertz
Standard Deviation 7.07
|
32 hertz
Standard Deviation 11.51
|
30 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
35 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
|
Aided Hearing Thresholds
Frequency 6000
|
26.71 hertz
Standard Deviation 5.30
|
37.64 hertz
Standard Deviation 8.99
|
35 hertz
Standard Deviation 10.48
|
37 hertz
Standard Deviation 10.37
|
25 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
30 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
|
Aided Hearing Thresholds
Frequency 8000
|
30.43 hertz
Standard Deviation 6.52
|
37.5 hertz
Standard Deviation 8.49
|
38.33 hertz
Standard Deviation 17.22
|
44 hertz
Standard Deviation 12.94
|
25 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
30 hertz
Standard Deviation NA
Standard Deviation not calculable for 1 participant.
|
SECONDARY outcome
Timeframe: Day 1Population: This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Aided speech-in-noise performance was measured in decibels.
Outcome measures
| Measure |
BAHA Implant
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Speech-in-noise Performance in Participants With Single-sided Deafness
Speech front / Noise Front
|
1.75 dB
Standard Deviation 2.46
|
1.81 dB
Standard Deviation 2.25
|
—
|
—
|
—
|
—
|
|
Aided Speech-in-noise Performance in Participants With Single-sided Deafness
Speech poorer ear / Noise better ear
|
2 dB
Standard Deviation 4.51
|
5.75 dB
Standard Deviation 3.87
|
—
|
—
|
—
|
—
|
|
Aided Speech-in-noise Performance in Participants With Single-sided Deafness
Speech better ear / noise poorer ear
|
-2.31 dB
Standard Deviation 2.34
|
-4.31 dB
Standard Deviation 1.83
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on their abutment and the Adhear device in the test booth on day 1. Aided speech-in-noise performance was measured in decibels.
Outcome measures
| Measure |
BAHA Implant
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Speech front / Noise Front
|
0.75 dB
Standard Deviation 0.35
|
-0.5 dB
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Speech poorer ear / Noise better ear
|
-3 dB
Standard Deviation 3.54
|
-1.75 dB
Standard Deviation 2.47
|
—
|
—
|
—
|
—
|
|
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Speech better ear / noise poorer ear
|
-6.5 dB
Standard Deviation 0.00
|
-6.5 dB
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: This outcome measure corresponds to Aim 1. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Aided speech-in-noise performance was measured in decibels.
Outcome measures
| Measure |
BAHA Implant
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Speech in Noise Performance in Participants With Single-sided Deafness
Speech front/noise front
|
0.5 dB
Standard Deviation 1.98
|
0.875 dB
Standard Deviation 1.53
|
—
|
—
|
—
|
—
|
|
Aided Speech in Noise Performance in Participants With Single-sided Deafness
Speech poorer ear/noise better ear
|
3.81 dB
Standard Deviation 3.54
|
3.69 dB
Standard Deviation 4.29
|
—
|
—
|
—
|
—
|
|
Aided Speech in Noise Performance in Participants With Single-sided Deafness
Speech better ear/noise poorer ear
|
-4.25 dB
Standard Deviation 2.58
|
-4.19 dB
Standard Deviation 2.55
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: This outcome measure corresponds to Aim 2. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Aided speech-in-noise performance is the ability to identify spoken words when background noise is present while using a hearing device. Aided speech-in-noise performance was measured using the participant's own device on a softband and the Adhear device in the test booth on day 14. Aided speech-in-noise performance was measured in decibels.
Outcome measures
| Measure |
BAHA Implant
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Speech front/noise front
|
-1.5 dB
Standard Deviation 0.71
|
-2.25 dB
Standard Deviation 1.77
|
—
|
—
|
—
|
—
|
|
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Speech poorer ear/noise better ear
|
-0.5 dB
Standard Deviation 3.54
|
-1.5 dB
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
|
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Speech better ear/noise poorer ear
|
-7 dB
Standard Deviation 0.71
|
-7.5 dB
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: This outcome measure corresponds to Aims 1, 2, 3, 3a, and 3b. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire.
Outcome measures
| Measure |
BAHA Implant
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
n=28 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
n=14 Participants
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
n=3 Participants
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3)
Subject
|
3.28 score on a scale
Standard Deviation 0.091
|
3.88 score on a scale
Standard Deviation 1.09
|
2.43 score on a scale
Standard Deviation 0.52
|
2.27 score on a scale
Standard Deviation 0.80
|
2.06 score on a scale
Standard Deviation 1.37
|
—
|
|
Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3)
Parent
|
—
|
—
|
2.55 score on a scale
Standard Deviation 0.52
|
2.71 score on a scale
Standard Deviation 0.51
|
3.03 score on a scale
Standard Deviation 0.59
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: This outcome measure corresponds to Aims 1, 2, 3, 3a, and 3b. Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire.
Outcome measures
| Measure |
BAHA Implant
n=8 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
n=28 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
n=14 Participants
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
n=3 Participants
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Participant Satisfaction With Adhear
Subject
|
3.22 score on a scale
Standard Deviation 0.86
|
3.54 score on a scale
Standard Deviation 0.72
|
2.88 score on a scale
Standard Deviation 0.51
|
3.38 score on a scale
Standard Deviation 0.56
|
3.33 score on a scale
Standard Deviation 1.20
|
—
|
|
Participant Satisfaction With Adhear
Parent
|
—
|
—
|
2.99 score on a scale
Standard Deviation 0.57
|
3.01 score on a scale
Standard Deviation 0.71
|
3.24 score on a scale
Standard Deviation 0.94
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: This outcome measure corresponds to Aim 3b.Overall number of participants analyzed are those participants who received the intervention and/or completed up to the visit.
Custom Subjective Device Questionnaire measured auditory, social emotional, and device satisfaction as a composite score using a Likert scale. Likert score range was 1-4. Higher scores denoted positive responses. The reported values represent an average across the multiple domains of the questionnaire.
Outcome measures
| Measure |
BAHA Implant
n=3 Participants
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with their BAHA
|
Adhear Pre
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with the Adhear.
|
BAHA Unilateral Conductive Hearing Loss Prior BAI Use
Device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant were tested with a BAHA. Participant can have unilateral or bilateral conductive hearing loss.
|
Adhear Unilateral Conductive Hearing Loss Prior BAI Use
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 2 weeks ± 90 days.
|
BAHA Bilateral Conductive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
Adhear Bilateral Conducive Hearing Loss Prior BAI Use
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age with a bone conduction device attached to a softband. Subjects will be given the ADHEAR bone conduction system on trial for 4 weeks ± 7 days.
|
|---|---|---|---|---|---|---|
|
Participant Satisfaction With Adhear at Day 28 (Aim 3b)
Subject
|
2.87 score on a scale
Standard Deviation 0.48
|
—
|
—
|
—
|
—
|
—
|
|
Participant Satisfaction With Adhear at Day 28 (Aim 3b)
Parent
|
2.94 score on a scale
Standard Deviation 0.49
|
—
|
—
|
—
|
—
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Adverse Events
Single-Sided Deafness Adult (Aim1) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conductive Hearing Loss Adult (Aim 2) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adhear (Aim 3) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BAHA (Aim 3) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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