Principal Investigator
Enrollment Status
Clinical Trial ID
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.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Other
Enrollment 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.