Adhear Bone Conduction System

  • STATUS
    Recruiting
  • End date
    Sep 1, 2021
  • participants needed
    90
  • sponsor
    University of Miami
Updated on 24 January 2021
ct scan
deafness
audiometry
bilateral conductive hearing loss
conditioning play audiometry

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.

Details
Condition Unilateral hearing loss, Conductive hearing loss
Treatment Standard of Care, Adhear Bone Conduction System, Bone anchored hearing aid (BAHA)
Clinical Study IdentifierNCT03533686
SponsorUniversity of Miami
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 2 yrs?
Gender: Male or Female
Do you have any of these conditions: Conductive hearing loss or Unilateral hearing loss?
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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