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Adhear Bone Conduction System
Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2018
CompletedFirst Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2022
CompletedResults Posted
Study results publicly available
August 8, 2023
CompletedAugust 8, 2023
July 1, 2023
3.9 years
April 30, 2018
April 6, 2023
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (7)
Aided Speech-in-noise Performance in Participants With Single-sided Deafness
Day 1
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Day 1
Aided Speech in Noise Performance in Participants With Single-sided Deafness
Day 14
Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
Day 14
Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3)
Day 1
- +2 more secondary outcomes
Study Arms (6)
Single-Sided Deafness Adult (Aim1) Group
EXPERIMENTALAdult 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).
Conductive Hearing Loss Adult (Aim 2) Group
EXPERIMENTALAdult 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 followed by BAHA (Aim 3) Group
EXPERIMENTALPediatric 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).
BAHA followed by Adhear (Aim 3) Group
EXPERIMENTALPediatric 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 Unilateral Conductive Hearing Loss (Aim 3a) Group
EXPERIMENTALPediatric 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 Bilateral Conductive Hearing Loss (Aim 3b) Group
EXPERIMENTALPediatric 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).
Interventions
Non-invasive bone conduction hearing device using adhesive
Non-invasive bone conduction hearing device using a headband
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Med-El Corporationcollaborator
Study Sites (1)
University of Miami Department of Otolaryngology
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hillary Snapp
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Hillary Snapp, PhD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 23, 2018
Study Start
April 26, 2018
Primary Completion
March 18, 2022
Study Completion
March 18, 2022
Last Updated
August 8, 2023
Results First Posted
August 8, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share