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

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The primary objective of this study is to compare the SoundBite™ Hearing System to
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
We found this trial at
3
sites
San Antonio, Texas 78240
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Novi, Michigan 48374
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Phoenix, Arizona 85004
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Phoenix, AZ
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