1630 - Hypoglossal nerve stimulation using the Genio System for the treatment of moderate to severe obstructive sleep apnoea (OSA) in patients who have failed or are intolerant to continuous positive airway pressure (CPAP)

Page last updated: 26 August 2020

Application Detail

Description of Medical Service

The Genio system is a medical device for the treatment of obstructive sleep apnoea (OSA). It has two key components:
• The Genio implantable stimulator – This device is implanted on the hypoglossal nerve during a surgical procedure of approximately 90 minutes.
• The Activation Chip & Disposable Patch – The activation chip contains a rechargeable battery and activates the Genio implantable stimulator by wireless energy transmission while the patient is asleep.
The Genio system is designed to treat moderate to severe OSA patients via hypoglossal nerve stimulation. The hypoglossal nerve is the main nerve controlling tongue movement. Direct stimulation of this nerve moves the tongue forward and increases pharyngeal muscles tone. In turn, this prevents the collapse of the airway and maintains breathing space for the patient.

Description of Medical Condition

OSA is a sleep condition where the muscles and soft tissues in the throat and tongue relax too much and collapse. This leads to repeated episodes of obstruction of the airway and cessation of breathing during sleep, in turn resulting in a reduction in blood oxygen saturation. Common symptoms of OSA are daytime sleepiness, restless sleep and loud snoring. Patients with OSA also have an increased risk of insulin resistance (Type 2 diabetes), dyslipidaemia, vascular disease and death.

Reason for Application

New MBS item

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1442 KB)
Application Form (Word 338 KB)

Consultation Survey

Consultation Survey (PDF 560 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

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ESC

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MSAC

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