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February 8, 2021

FDA grants marketing approval for sleep apnea reduction device

The US Food and Drug Administration (FDA) has granted marketing authorisation of eXciteOSA device to Signifier Medical Technologies.

The US Food and Drug Administration (FDA) has granted marketing authorisation of eXciteOSA device to Signifier Medical Technologies.

The new prescription-only device is intended to reduce snoring and mild obstructive sleep apnea (OSA) in people aged 18 years and older.

OSA is common sleep-disordered breathing that has potentially serious effects in the long term. It is caused when the upper airway becomes blocked repeatedly during sleep, minimising or fully stopping airflow.

If left untreated, OSA can lead to serious conditions, including heart attack, diabetes, glaucoma, cancer, as well as cognitive and behavioural disorders.

Considered to be the first device to be used while awake, eXciteOSA is designed to boost tongue muscle function by providing electrical muscle stimulation via a mouthpiece that sits around the tongue.

It helps to prevent the tongue from collapsing backwards and obstructing the airway during sleep.

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FDA Center for Devices and Radiological Health, Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices director Malvina Eydelman said: “Obstructive sleep apnea not only impacts sleep quality but can have other serious health impacts if untreated. Today’s authorisation offers a new option for the thousands of individuals who experience snoring or mild sleep apnea.”

The eXciteOSA mouthpiece features four electrodes, two located above the tongue and two located below the tongue. The device delivers electrical muscle stimulation action in sessions that combine a series of electrical pulses and rest periods in between.

It is prescribed to be used for 20 minutes once a day when the patient is awake for a period of six weeks and once a week afterwards.

The FDA evaluated the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild sleep apnea.

The study found that the time spent snoring at levels louder than 40dB came down by over 20% in 87 out of the 115 patients. Furthermore, the average AHI reduced by 48% in 41 of the 48-patient subset with both snoring and mild sleep apnea.

Excessive salivation, tongue-tingling, tongue, or tooth discomfort, dental filling sensitivity, gagging metallic taste, and tight jaw were among the most common adverse events observed in the patients.

In 2018, Royal Philips acquired Dutch digital health scale-up company NightBalance, which specialises in developing medical devices for the treatment of sleep disorders.

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