In 1993, the first model of The Silencer® family was introduced: The Silencer® Professional, using the titanium Halstrom Hinge . The Silencer® received 510K Clearance in November 1995 from the U.S.A. Food and Drug Administration.
The Silencer® Professional is constructed from acrylic and elastomeric dental materials. It requires the services of a dental laboratory trained in the fabrication of The Silencer® appliances. It is the most compact oral appliance in The Silencer® family of products. The Silencer® Professional is SPI s full-featured product and has an average product life of three to five years. The HH1000/3000 Halstrom Hinge is warranted for a period of five years and is reusable at the stage where the body of the appliance has worn out.
Once the patient has been diagnosed with OSDB and determined to be a candidate for airway dilation, fitting The Silencer® Professional model requires the following steps:
- An impression is made of the patient s teeth at a dental office;
- Measurements of the forward and sideways maximum movements of the jaw are recorded using a GAT gothic arch tracer;
- The impression is sent to the dental laboratory for manufacturing and assembly of The Silencer® Professional with the Halstrom Hinge .
- The patient returns to the sleep professional s office for fitting;
- The patient is required to return for follow-up appointments, which may include adjusting the Halstrom Hinge to achieve the optimum setting for airway dilation.
