Clinical trial: Adhear Bone Conduction System (NCT03533686)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.


Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction