Hearing Loss, Conductive, Hearing Loss, Unilateral
Conditions
Brief summary
The purpose of this research study is to learn about the hearing outcomes of adult and pediatric patients who are treated with or are candidates for bone conductive devices (also termed BAHA). Hearing outcomes will also be assessed with a second audio processor device called the Adhear System.
Interventions
DEVICEAdhear Bone Conduction System
Non-invasive bone conduction hearing device using adhesive
DEVICEBone anchored hearing aid (BAHA)
Non-invasive bone conduction hearing device using a headband
Sponsors
Med-El Corporation
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants who are enrolled in Aims 3 are part of a cross-over design. Participants in this group will be randomly assigned to either standard of care followed by Adhear, or Adhear followed by standard of care.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aims 1 and 2: * Adult English speaking patients who are experienced users of Bone Anchored Implants (BAIs) for the indication of either single sided deafness or conductive hearing loss. * Experienced will be defined as greater than 6 months of device use and no intermittent function of the device within 2 weeks of enrollment. * Subjects will be limited to those who have normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, & 3000 Hz in at least one ear. Aim 3: * English speaking children 5 to 17 years of age and their primary guardian who present to the clinic for treatment by BAI on a headband device for the indications of single sided deafness or conductive hearing loss. * Subjects will be limited to those who have no prior use of a BAI or bone conduction hearing device, normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, & 3000 Hz in at least one ear. For those children where this cannot be definitively established, children will be included who display clinical signs of normal bone conduction hearing beyond a reasonable doubt and may include such evidence as (but not limited to): auditory brainstem response, speech awareness thresholds, visual reinforcement audiometry, conditioning play audiometry, CT scans, etc.) Aim 3 a & b: * Pediatric bilateral or unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age * Pediatric participants who are currently managed by the University of Miami with a bone conduction device attached to a softband.
Exclusion criteria
Aims 1 & 2: * Non-English speakers * Participants reporting allergies to adhesives or highly reactive skin. Aim 3: * Pediatric participants who are non-English speakers. * Children who have previous experience with a BAI or bone conduction hearing device will not be included for study. * Pediatric participants reporting allergies to adhesives or highly reactive skin. Aims 3a & 3b: * Pediatric participants who are non-English speakers. * Pediatric participants reporting allergies to adhesives or highly reactive skin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aided Hearing Thresholds for Single Sided Deafness | Day 1 | 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. |
| Aided Hearing Thresholds for Conductive Hearing Loss | Day 1 | 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. |
| Aided Hearing Thresholds | Day 14 of the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Day 1 | 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. |
| Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Day 1 | 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. |
| Participant Satisfaction With Adhear at Day 28 (Aim 3b) | Day 28 | 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. |
| Participant Satisfaction With Adhear | Day 14 | 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. |
| Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Day 1 | 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. |
| Aided Speech in Noise Performance in Participants With Single-sided Deafness | Day 14 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| 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 | 3 |
| 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 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 | 18 |
| 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 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 | 15 |
| 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 | 17 |
| 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 | 4 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 2 | 0 |
| Overall Study | Screen Failure | 0 | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 3 | 5 | 1 |
Baseline characteristics
| Characteristic | Single-Sided Deafness Adult (Aim1) Group | Conductive Hearing Loss Adult (Aim 2) Group | Adhear Followed by BAHA (Aim 3) Group | BAHA Followed by Adhear (Aim 3) Group | Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group | Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 9 Participants | 7 Participants | 8 Participants | 2 Participants | 26 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 3 Participants | 9 Participants | 8 Participants | 9 Participants | 2 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 1 Participants | 9 Participants | 9 Participants | 11 Participants | 3 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 6 Participants | 5 Participants | 3 Participants | 0 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 7 Participants | 5 Participants | 5 Participants | 0 Participants | 18 Participants |
| Race (NIH/OMB) White | 7 Participants | 2 Participants | 11 Participants | 10 Participants | 11 Participants | 4 Participants | 45 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 11 Participants | 8 Participants | 12 Participants | 3 Participants | 41 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 7 Participants | 7 Participants | 5 Participants | 1 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 3 | 0 / 33 | 0 / 33 | 0 / 14 | 0 / 4 |
| other Total, other adverse events | 0 / 8 | 0 / 3 | 0 / 33 | 0 / 33 | 0 / 14 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 3 | 0 / 33 | 0 / 33 | 0 / 14 | 0 / 4 |
Outcome results
Primary
Aided Hearing Thresholds
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.
Time frame: Day 14 of the intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Hearing Thresholds | Frequency 1000 | 13.64 hertz | Standard Deviation 7.47 |
| BAHA Implant | Aided Hearing Thresholds | Frequency 500 | 15.64 hertz | Standard Deviation 6.54 |
| BAHA Implant | Aided Hearing Thresholds | Frequency 250 | 19.43 hertz | Standard Deviation 6.44 |
| BAHA Implant | Aided Hearing Thresholds | Frequency 2000 | 18.86 hertz | Standard Deviation 5.17 |
| BAHA Implant | Aided Hearing Thresholds | Frequency 3000 | 24.43 hertz | Standard Deviation 6.85 |
| BAHA Implant | Aided Hearing Thresholds | Frequency 4000 | 26.50 hertz | Standard Deviation 5.81 |
| BAHA Implant | Aided Hearing Thresholds | Frequency 6000 | 26.71 hertz | Standard Deviation 5.3 |
| BAHA Implant | Aided Hearing Thresholds | Frequency 8000 | 30.43 hertz | Standard Deviation 6.52 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 2000 | 24.86 hertz | Standard Deviation 6.71 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 8000 | 37.5 hertz | Standard Deviation 8.49 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 250 | 28 hertz | Standard Deviation 9.76 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 6000 | 37.64 hertz | Standard Deviation 8.99 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 4000 | 39.71 hertz | Standard Deviation 8.48 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 1000 | 21.43 hertz | Standard Deviation 4.97 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 500 | 24.57 hertz | Standard Deviation 7.51 |
| Adhear Pre | Aided Hearing Thresholds | Frequency 3000 | 34 hertz | Standard Deviation 8.23 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 500 | 22.50 hertz | Standard Deviation 5.24 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 1000 | 22.50 hertz | Standard Deviation 8.22 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 2000 | 22.50 hertz | Standard Deviation 4.18 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 8000 | 38.33 hertz | Standard Deviation 17.22 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 3000 | 30 hertz | Standard Deviation 6.32 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 4000 | 30 hertz | Standard Deviation 7.07 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 6000 | 35 hertz | Standard Deviation 10.48 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 250 | 24.17 hertz | Standard Deviation 2.04 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 6000 | 37 hertz | Standard Deviation 10.37 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 4000 | 32 hertz | Standard Deviation 11.51 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 3000 | 28 hertz | Standard Deviation 12.54 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 250 | 24 hertz | Standard Deviation 7.41 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 1000 | 22 hertz | Standard Deviation 6.71 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 2000 | 27 hertz | Standard Deviation 8.36 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 8000 | 44 hertz | Standard Deviation 12.94 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 500 | 21 hertz | Standard Deviation 6.52 |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 8000 | 25 hertz | — |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 250 | 15 hertz | — |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 3000 | 30 hertz | — |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 4000 | 30 hertz | — |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 6000 | 25 hertz | — |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 500 | 10 hertz | — |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 1000 | 15 hertz | — |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 2000 | 15 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 8000 | 30 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 3000 | 40 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 1000 | 20 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 2000 | 20 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 4000 | 35 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 500 | 15 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 6000 | 30 hertz | — |
| Adhear Bilateral Conducive Hearing Loss Prior BAI Use | Aided Hearing Thresholds | Frequency 250 | 30 hertz | — |
Primary
Aided Hearing Thresholds for Conductive Hearing Loss
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 250 | 17.5 hertz | Standard Deviation 3.54 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 500 | 12.5 hertz | Standard Deviation 10.61 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 1000 | 22.50 hertz | Standard Deviation 3.54 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 2000 | 27.5 hertz | Standard Deviation 3.54 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 3000 | 35 hertz | Standard Deviation 0 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 4000 | 37.5 hertz | Standard Deviation 10.61 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 6000 | 40 hertz | Standard Deviation 14.14 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 8000 | 47.5 hertz | Standard Deviation 3.54 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 8000 | 55 hertz | Standard Deviation 7.07 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 250 | 27.5 hertz | Standard Deviation 3.54 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 3000 | 40 hertz | Standard Deviation 7.07 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 500 | 20 hertz | Standard Deviation 0 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 6000 | 50 hertz | Standard Deviation 7.07 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 1000 | 22.5 hertz | Standard Deviation 3.54 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 4000 | 55 hertz | Standard Deviation 7.07 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 2000 | 30 hertz | Standard Deviation 7.07 |
Primary
Aided Hearing Thresholds for Conductive Hearing Loss
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 3000 | 35 hertz | Standard Deviation 0 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 250 | 17.5 hertz | Standard Deviation 3.54 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 4000 | 37.50 hertz | Standard Deviation 10.61 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 1000 | 22.5 hertz | Standard Deviation 3.54 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 6000 | 40 hertz | Standard Deviation 14.14 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 500 | 12.5 hertz | Standard Deviation 10.61 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 8000 | 47.5 hertz | Standard Deviation 3.54 |
| BAHA Implant | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 2000 | 27.5 hertz | Standard Deviation 3.54 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 8000 | 57.5 hertz | Standard Deviation 10.61 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 250 | 22.5 hertz | Standard Deviation 3.54 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 500 | 25 hertz | Standard Deviation 14.14 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 1000 | 17.5 hertz | Standard Deviation 3.54 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 3000 | 47.5 hertz | Standard Deviation 10.61 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 4000 | 55 hertz | Standard Deviation 14.14 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 6000 | 50 hertz | Standard Deviation 14.14 |
| Adhear Pre | Aided Hearing Thresholds for Conductive Hearing Loss | Frequency 2000 | 35 hertz | Standard Deviation 14.14 |
Primary
Aided Hearing Thresholds for Single Sided Deafness
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 250 | 36.25 hertz | Standard Deviation 7.44 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 500 | 28.13 hertz | Standard Deviation 6.51 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 1000 | 20 hertz | Standard Deviation 2.67 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 2000 | 23.13 hertz | Standard Deviation 2.59 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 3000 | 27.5 hertz | Standard Deviation 5.35 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 4000 | 33.13 hertz | Standard Deviation 5.94 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 6000 | 31.88 hertz | Standard Deviation 6.51 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 8000 | 40 hertz | Standard Deviation 11.65 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 8000 | 56.88 hertz | Standard Deviation 7.53 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 250 | 35.63 hertz | Standard Deviation 10.16 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 3000 | 44.38 hertz | Standard Deviation 4.17 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 500 | 37.50 hertz | Standard Deviation 7.07 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 6000 | 56.88 hertz | Standard Deviation 5.3 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 1000 | 30.63 hertz | Standard Deviation 6.23 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 4000 | 51.25 hertz | Standard Deviation 6.94 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 2000 | 35.00 hertz | Standard Deviation 8.45 |
Primary
Aided Hearing Thresholds for Single Sided Deafness
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 250 | 37.5 hertz | Standard Deviation 6.78 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 500 | 31.75 hertz | Standard Deviation 9.11 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 1000 | 24.38 hertz | Standard Deviation 7.01 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 2000 | 28.88 hertz | Standard Deviation 6.6 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 3000 | 35.38 hertz | Standard Deviation 6.91 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 4000 | 45.25 hertz | Standard Deviation 6.36 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 6000 | 46.5 hertz | Standard Deviation 10.73 |
| BAHA Implant | Aided Hearing Thresholds for Single Sided Deafness | Frequency 8000 | 50.50 hertz | Standard Deviation 6.37 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 8000 | 54.25 hertz | Standard Deviation 7.21 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 250 | 31.88 hertz | Standard Deviation 11.27 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 3000 | 42.88 hertz | Standard Deviation 4.82 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 500 | 32.13 hertz | Standard Deviation 9.63 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 6000 | 53.88 hertz | Standard Deviation 7.51 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 1000 | 28.38 hertz | Standard Deviation 4.98 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 4000 | 50.75 hertz | Standard Deviation 7.8 |
| Adhear Pre | Aided Hearing Thresholds for Single Sided Deafness | Frequency 2000 | 31.75 hertz | Standard Deviation 7.4 |
Secondary
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech front / Noise Front | 0.75 dB | Standard Deviation 0.35 |
| BAHA Implant | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech poorer ear / Noise better ear | -3 dB | Standard Deviation 3.54 |
| BAHA Implant | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech better ear / noise poorer ear | -6.5 dB | Standard Deviation 0 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech front / Noise Front | -0.5 dB | Standard Deviation 0.71 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech poorer ear / Noise better ear | -1.75 dB | Standard Deviation 2.47 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech better ear / noise poorer ear | -6.5 dB | Standard Deviation 1.41 |
Secondary
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech better ear/noise poorer ear | -7 dB | Standard Deviation 0.71 |
| BAHA Implant | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech front/noise front | -1.5 dB | Standard Deviation 0.71 |
| BAHA Implant | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech poorer ear/noise better ear | -0.5 dB | Standard Deviation 3.54 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech front/noise front | -2.25 dB | Standard Deviation 1.77 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech poorer ear/noise better ear | -1.5 dB | Standard Deviation 2.83 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Conductive Hearing Loss | Speech better ear/noise poorer ear | -7.5 dB | Standard Deviation 0 |
Secondary
Aided Speech-in-noise Performance in Participants With Single-sided Deafness
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Speech front / Noise Front | 1.75 dB | Standard Deviation 2.46 |
| BAHA Implant | Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Speech poorer ear / Noise better ear | 2 dB | Standard Deviation 4.51 |
| BAHA Implant | Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Speech better ear / noise poorer ear | -2.31 dB | Standard Deviation 2.34 |
| Adhear Pre | Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Speech front / Noise Front | 1.81 dB | Standard Deviation 2.25 |
| Adhear Pre | Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Speech poorer ear / Noise better ear | 5.75 dB | Standard Deviation 3.87 |
| Adhear Pre | Aided Speech-in-noise Performance in Participants With Single-sided Deafness | Speech better ear / noise poorer ear | -4.31 dB | Standard Deviation 1.83 |
Secondary
Aided Speech in Noise Performance in Participants With Single-sided Deafness
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Aided Speech in Noise Performance in Participants With Single-sided Deafness | Speech front/noise front | 0.5 dB | Standard Deviation 1.98 |
| BAHA Implant | Aided Speech in Noise Performance in Participants With Single-sided Deafness | Speech poorer ear/noise better ear | 3.81 dB | Standard Deviation 3.54 |
| BAHA Implant | Aided Speech in Noise Performance in Participants With Single-sided Deafness | Speech better ear/noise poorer ear | -4.25 dB | Standard Deviation 2.58 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Single-sided Deafness | Speech front/noise front | 0.875 dB | Standard Deviation 1.53 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Single-sided Deafness | Speech poorer ear/noise better ear | 3.69 dB | Standard Deviation 4.29 |
| Adhear Pre | Aided Speech in Noise Performance in Participants With Single-sided Deafness | Speech better ear/noise poorer ear | -4.19 dB | Standard Deviation 2.55 |
Secondary
Participant Satisfaction With Adhear
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Participant Satisfaction With Adhear | Subject | 3.22 score on a scale | Standard Deviation 0.86 |
| Adhear Pre | Participant Satisfaction With Adhear | Subject | 3.54 score on a scale | Standard Deviation 0.72 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With Adhear | Subject | 2.88 score on a scale | Standard Deviation 0.51 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With Adhear | Parent | 2.99 score on a scale | Standard Deviation 0.57 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With Adhear | Parent | 3.01 score on a scale | Standard Deviation 0.71 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With Adhear | Subject | 3.38 score on a scale | Standard Deviation 0.56 |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With Adhear | Parent | 3.24 score on a scale | Standard Deviation 0.94 |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With Adhear | Subject | 3.33 score on a scale | Standard Deviation 1.2 |
Secondary
Participant Satisfaction With Adhear at Day 28 (Aim 3b)
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | Participant Satisfaction With Adhear at Day 28 (Aim 3b) | Subject | 2.87 score on a scale | Standard Deviation 0.48 |
| BAHA Implant | Participant Satisfaction With Adhear at Day 28 (Aim 3b) | Parent | 2.94 score on a scale | Standard Deviation 0.49 |
Secondary
Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3)
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BAHA Implant | 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 |
| Adhear Pre | Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Subject | 3.88 score on a scale | Standard Deviation 1.09 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Subject | 2.43 score on a scale | Standard Deviation 0.52 |
| BAHA Unilateral Conductive Hearing Loss Prior BAI Use | 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 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Parent | 2.71 score on a scale | Standard Deviation 0.51 |
| Adhear Unilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Subject | 2.27 score on a scale | Standard Deviation 0.8 |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Parent | 3.03 score on a scale | Standard Deviation 0.59 |
| BAHA Bilateral Conductive Hearing Loss Prior BAI Use | Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3) | Subject | 2.06 score on a scale | Standard Deviation 1.37 |