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The SoundBite prosthetic device is intended for the following patients and indications: - Patients who are 18 years or older and have moderately severe, or profound . sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deathess or "SSD"). Normal hearing is defined as a pure tone average (PTA) airconduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of 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 . decav. 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.