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")
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
You may not be if
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
Clareo Health | 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")
