Back to resultsAdhear Bone Conduction System
Primary Purpose
Hearing Loss, Conductive, Hearing Loss, Unilateral
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adhear Bone Conduction System
Bone anchored hearing aid (BAHA)
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Conductive
Eligibility Criteria
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.
Sites / Locations
- University of Miami Department of Otolaryngology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
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
Arm Description
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).
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).
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).
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).
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).
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03533686
First Posted
April 30, 2018
Last Updated
July 19, 2023
Sponsor
University of Miami
Collaborators
Med-El Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03533686
Brief Title
Adhear Bone Conduction System
Official Title
Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruitment
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Med-El Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Conductive, Hearing Loss, Unilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Sided Deafness Adult (Aim1) Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Conductive Hearing Loss Adult (Aim 2) Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Adhear followed by BAHA (Aim 3) Group
Arm Type
Experimental
Arm Description
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).
Arm Title
BAHA followed by Adhear (Aim 3) Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Adhear Bone Conduction System
Intervention Description
Non-invasive bone conduction hearing device using adhesive
Intervention Type
Device
Intervention Name(s)
Bone anchored hearing aid (BAHA)
Intervention Description
Non-invasive bone conduction hearing device using a headband
Primary Outcome Measure Information:
Title
Aided Hearing Thresholds for Single Sided Deafness
Description
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
Title
Aided Hearing Thresholds for Conductive Hearing Loss
Description
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
Title
Aided Hearing Thresholds for Single Sided Deafness
Description
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
Title
Aided Hearing Thresholds for Conductive Hearing Loss
Description
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
Title
Aided Hearing Thresholds
Description
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
Secondary Outcome Measure Information:
Title
Aided Speech-in-noise Performance in Participants With Single-sided Deafness
Description
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
Title
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Description
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
Title
Aided Speech in Noise Performance in Participants With Single-sided Deafness
Description
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
Title
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Description
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
Title
Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3)
Description
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
Title
Participant Satisfaction With Adhear
Description
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
Title
Participant Satisfaction With Adhear at Day 28 (Aim 3b)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Snapp, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Department of Otolaryngology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adhear Bone Conduction System
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