Adhear Bone Conduction System

Hearing Loss, Conductive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03533686
• Other study ID #: 20161220
• Status: Terminated
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: March 18, 2022

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Unilateral

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Miami Department of Otolaryngology	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Med-El Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1
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.	Day 1
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.	Day 14
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.	Day 14
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.	Day 14 of the intervention
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.	Day 1
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.	Day 1
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.	Day 14
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.	Day 14
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.	Day 1
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.	Day 14
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.	Day 28