Adhear Bone Conduction System

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

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.

Study Overview

• Status: Terminated
• Conditions: Hearing Loss, Conductive; Hearing Loss, Unilateral
• Intervention / Treatment: Device: Adhear Bone Conduction System; Device: Bone anchored hearing aid (BAHA)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Department of Otolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Adhear Bone Conduction System; Non-invasive bone conduction hearing device using adhesive
Experimental: 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).	Device: Adhear Bone Conduction System; Non-invasive bone conduction hearing device using adhesive
Experimental: 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).	Device: Adhear Bone Conduction System; Non-invasive bone conduction hearing device using adhesive; Device: Bone anchored hearing aid (BAHA); Non-invasive bone conduction hearing device using a headband
Experimental: 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).	Device: Adhear Bone Conduction System; Non-invasive bone conduction hearing device using adhesive; Device: Bone anchored hearing aid (BAHA); Non-invasive bone conduction hearing device using a headband
Experimental: 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).	Device: Adhear Bone Conduction System; Non-invasive bone conduction hearing device using adhesive
Experimental: 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).	Device: Adhear Bone Conduction System; Non-invasive bone conduction hearing device using adhesive

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Med-El Corporation
• Investigators: Principal Investigator: Hillary Snapp, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Unilateral
• Other Study ID Numbers: 20161220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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