In-Ear Wearable May Predict Fainting

An earpiece measuring blood flow to the head 24/7 can help better understand dizziness and other symptoms that occur upon standing and are associated with long COVID.

STAT Health introduced a new device developed by researchers at Johns Hopkins, Brigham and Women's, and Harvard Medical School that may predict fainting minutes before it happens. The in-ear wearable, however, is not yet approved by the US Food and Drug Administration (FDA) as a wellness product.

Dizziness, brain fog, headaches, fainting, and fatigue upon standing are common in people with illnesses like long COVID, postural orthostatic tachycardia syndrome (POTS), and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) that affect more than 13 million Americans.

While these symptoms are known to be caused by reduced blood flow to the brain, until now, such a relationship has been difficult to prove experimentally.

Using ultrasound, the research team demonstrated that Cerebral Blood Flow, a method of quantifying blood flow to the head, is a key biomarker that objectively measures the presence and severity of many of these illnesses.

"However, it's not easy to measure CBF, so most clinics approximate using secondary metrics of Heart Rate and Blood Pressure, which often mislead. Unfortunately, this frequently leads to the wrong conclusion that the symptoms are just psychological, when in fact, there are physiological abnormalities," says Daniel Lee, co-founder and CEO of STAT Health.

To fit into a wearable form factor, STAT uses an optical sensor and taps into a shallow ear artery to measure a proxy to ultrasound-derived CBF. The device auto-detects a user's every stand to track changes in heart rate, blood pressure trend, and blood flow. After learning about a user's unique body, the device provides personalized coaching, such as information about hydration, salt intake, and other healthy lifestyle choices.

STAT is half the size of Bose sleepbuds and smaller than some invisible-in-the-canal hearing aids. It can be worn in-ear 24/7, even while sleeping and showering. The wearable co-exists with more than 90% of devices that go in/around the ear and can charge using solar while in-ear.

The device was peer-reviewed in the Journal of the American College of Cardiology. The trial included 20 patients between the ages of 18 to 85 with a suspected diagnosis of vasovagal syncope, a condition that may lead to fainting. The device recorded blood flow changes within four minutes before fainting.

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