Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
Status: | Completed |
---|---|
Conditions: | Other Indications, Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/2/2016 |
Start Date: | September 2013 |
End Date: | February 2014 |
Contact: | Linda Galow, M.S. |
Email: | linda@sonitusmedical.com |
Phone: | 1-650-581-5094 |
The primary objective of this study is to compare the SoundBite™ Hearing System to
surgically implanted BCD systems.
surgically implanted BCD systems.
Inclusion Criteria:
- Must be current users of a surgically implanted digitally programmable surgically
implanted bone conduction device
- Must be >18, <80 years old
- Must be fluent in English, as determined by the PI
- Must have diagnosis of SSD, time since onset (≥3 months)
- Must have at least two contiguous molar or premolar teeth with no untreated tooth
decay. Patients with tooth decay present are to first have restorations before being
fitted for SoundBite
- Healthy attachment to those teeth with tooth pockets limited to no more than 5mm
Exclusion Criteria:
- Subjects with known hypersensitivity to any of the components including allergies to
polymers.
- Subjects that are unable to use their hands such as quadriplegics or others that are
unable to comply with the warnings in the product's labeling.
- Subjects with known or active secondary medical conditions associated with variable
sensorineural hearing loss
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