Adhear Bone Conduction System
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 5/25/2018 |
| Start Date: | April 26, 2018 |
| End Date: | May 15, 2019 |
| Contact: | Constanza Pelusso, MD |
| Email: | cpelusso@med.miami.edu |
| Phone: | 305-243-7102 |
Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices
Standard treatment for single-sided deafness and conductive hearing loss includes bone
anchored implants. Such devices have been well established as safe and effective, however
require surgical procedure and lifelong use of an implant. Similar results can be achieved
using the same auditory processors from the implantable system coupled to a headband with the
processor worn at the impaired mastoid. While non-invasive, the use of a headband is
complicated by discomfort with longterm use and stigma associated with the visibility of the
device. The Adhear bone conduction system (MEDEL Corp) uses a novel longwear adhesive to
allow for non-invasive use of the audio processor without the discomfort or stigma associated
with traditional headband use. Bone conduction hearing systems have the ability to provide
immediate and sustainable benefit in these specified hearing loss populations, but have seen
varying levels of adoption and acceptance because of the limiting factors surrounding the
need for surgery or use of a large and uncomfortable headband. This study will investigate
the hearing outcomes and adoption and acceptance of the Adhear bone conduction system.
anchored implants. Such devices have been well established as safe and effective, however
require surgical procedure and lifelong use of an implant. Similar results can be achieved
using the same auditory processors from the implantable system coupled to a headband with the
processor worn at the impaired mastoid. While non-invasive, the use of a headband is
complicated by discomfort with longterm use and stigma associated with the visibility of the
device. The Adhear bone conduction system (MEDEL Corp) uses a novel longwear adhesive to
allow for non-invasive use of the audio processor without the discomfort or stigma associated
with traditional headband use. Bone conduction hearing systems have the ability to provide
immediate and sustainable benefit in these specified hearing loss populations, but have seen
varying levels of adoption and acceptance because of the limiting factors surrounding the
need for surgery or use of a large and uncomfortable headband. This study will investigate
the hearing outcomes and adoption and acceptance of the Adhear bone conduction system.
Inclusion Criteria:
Arms 1 and 2
- Adult English speaking patients
- Experienced users of bone conduction devices as greater than 6 months of device use
- Single sided deafness or conductive hearing loss
- 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.
Arm 3
- English speaking children 5 to 17 years of age
- Single sided deafness or Conductive hearing loss
- No prior use of a 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.
- Guardian of child
Exclusion Criteria:
Arms 1 & 2
- Non-english speakers
- Patient's who are not actively using their implant or has had intermittent function of
their implant in the last 6 months
Arm 3
- Parents of English speaking subjects who do not speak English will not be specifically
excluded. Due to the high incidence of English speaking children in Spanish speaking
homes, for primary guardians who speak Spanish, Spanish materials (subjective
questionnaires and parental consent) will be provided.
- Enrolled children must have English language proficiency, as speech perception
measures are only available in English.
- Children who have previous experience with a bone conduction hearing device will not
be included for study.
- Allergies related to adhesives as the experimental device requires use of an adhesive
adapter.
We found this trial at
1
site
Miami, Florida 33136
Principal Investigator: Hillary Snapp, AuD, PhD
Phone: 305-243-7102
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