Adhear Bone Conduction System

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices

Conditions
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Hearing Loss, Conductive, Hearing Loss, Unilateral

Intervention / Treatment
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* Device: Adhear Bone Conduction System
* Device: Bone anchored hearing aid (BAHA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-Sided Deafness Adult (Aim1) Group<br>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). | Device: Adhear Bone Conduction System<br>* Non-invasive bone conduction hearing device using adhesive<br>|
| Experimental: Conductive Hearing Loss Adult (Aim 2) Group<br>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). | Device: Adhear Bone Conduction System<br>* Non-invasive bone conduction hearing device using adhesive<br>|
| Experimental: Adhear followed by BAHA (Aim 3) Group<br>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). | Device: Adhear Bone Conduction System<br>* Non-invasive bone conduction hearing device using adhesive<br>Device: Bone anchored hearing aid (BAHA)<br>* Non-invasive bone conduction hearing device using a headband<br>|
| Experimental: BAHA followed by Adhear (Aim 3) Group<br>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). | Device: Adhear Bone Conduction System<br>* Non-invasive bone conduction hearing device using adhesive<br>Device: Bone anchored hearing aid (BAHA)<br>* Non-invasive bone conduction hearing device using a headband<br>|
| Experimental: Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group<br>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). | Device: Adhear Bone Conduction System<br>* Non-invasive bone conduction hearing device using adhesive<br>|
| Experimental: Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group<br>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). | Device: Adhear Bone Conduction System<br>* Non-invasive bone conduction hearing device using adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 14 | 
| 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. | Day 14 | 
| 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. | Day 14 of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 14 | 
| 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. | Day 14 | 
| 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. | Day 1 | 
| 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. | Day 14 | 
| 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. | Day 28 |