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The SoundBite Hearing System is intended for patients 18 years and older with the following indications: - Patients with moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL. - Patients with conductive hearing loss where the average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL. Additionally, use of SoundBite is intended for patients with: - 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; - No mobile teeth; - Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.

The SoundBite Hearing System by Sonitus Medical consists of two main components; a behind the ear (BTE) microphone unit and an in the mouth (ITM) hearing device. Accessories include a system charger and programming software. The BTE uses a digital signal processor to process the sound and a wireless chip to transmit the signals to the hearing device worn in the mouth. The ITM hearing device in turn creates imperceptible vibrations using a piezoelectric actuator that are sent via the teeth, through the skull bones, and ultimately to the cochleae.