Clinical trial NCT03533686: Adhear Bone Conduction System
Official title: Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss, Conductive
Hearing Loss, Unilateral
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Med-El Corporation
First posted: 2018-05-23
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Aided Hearing Thresholds for Single Sided Deafness
timeFrame: Day 1
measure: Aided Hearing Thresholds for Conductive Hearing Loss
timeFrame: Day 1
measure: Aided Hearing Thresholds for Single Sided Deafness
timeFrame: Day 14
measure: Aided Hearing Thresholds for Conductive Hearing Loss
timeFrame: Day 14
measure: Aided Hearing Thresholds
timeFrame: Day 14 of the intervention
Secondary outcomes:
measure: Aided Speech-in-noise Performance in Participants With Single-sided Deafness
timeFrame: Day 1
measure: Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
timeFrame: Day 1
measure: Aided Speech in Noise Performance in Participants With Single-sided Deafness
timeFrame: Day 14
measure: Aided Speech in Noise Performance in Participants With Conductive Hearing Loss
timeFrame: Day 14
measure: Participant Satisfaction With BAHA (Aims 1, 2, 3a and 3b) or No Device (Aim 3)
timeFrame: Day 1
measure: Participant Satisfaction With Adhear
timeFrame: Day 14
measure: Participant Satisfaction With Adhear at Day 28 (Aim 3b)
timeFrame: Day 28
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Department of Otolaryngology
state: Florida
Study officials:
affiliation: University of Miami
name: Hillary Snapp, PhD
role: PRINCIPAL_INVESTIGATOR
References: