Product Description

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Manual of SoundBite Hearing System G3/G3S
Table of Content
1 Product Description
2 Operating Instructions
3 Cleaning and Daily Care
4 Troubleshooting
5 Warnings and Cautions
6 Symbol Table
7 Technical Description
8 Warranty
9 EMC Compliance Statement
10 Parts List
1. Product Description
The SoundBite Hearing System is a non-surgical and removable bone conduction
hearing device designed to transmit sound through the teeth.
1.1 Intended use of product:
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 4 kHz) of better than or equal to 25
dB HL.
- Patients with conductive hearing loss where the pure tone average
bone-conduction hearing threshold (measured at 0.5, 1, 2, and 4 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.