Adhear Bone Conduction System (NCT03533686) | Clinical Trial Compass
TerminatedNot Applicable
Adhear Bone Conduction System
Stopped: Difficulty in recruitment
United States66 participantsStarted 2018-04-26
Plain-language 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.
Who can participate
Age range2 Years
SexALL
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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…
What they're measuring
1
Aided Hearing Thresholds for Single Sided Deafness
Timeframe: Day 1
2
Aided Hearing Thresholds for Conductive Hearing Loss
Timeframe: Day 1
3
Aided Hearing Thresholds for Single Sided Deafness
Timeframe: Day 14
4
Aided Hearing Thresholds for Conductive Hearing Loss