Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Pr… (NCT01933386) | Clinical Trial Compass
UnknownPhase 4
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")
United States15 participantsStarted 2013-09
Plain-language summary
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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