Medical Devices & Technology Archive

They're not yet FDA-approved, but the devices are available and safe — if you know what to look for.

When Congress passed the Over-the-Counter (OTC) Hearing Aid Act in 2017, it opened up a new world of possibility for people with hearing loss. Instead of paying $5,000 for a pair of FDA-approved hearing aids and follow-up service, you could pay hundreds of dollars for an OTC pair from any seller — no doctor appointments, hearing tests, or fittings needed. The devices would have the same fundamental technology as traditional hearing aids, they'd be targeted to people with perceived mild-to-moderate hearing loss, and the FDA would ensure quality by regulating and approving the OTC devices.

But almost four years later, the OTC hearing aid category and its safety and labeling rules are still tied up in red tape.

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Wearable activity or fitness trackers and smartphone apps are helpful for goal setting and measuring how many steps you take or how much time you spend exercising. But do they motivate you to become more active? Probably a little, finds a review of randomized controlled trials published online Dec. 21, 2020, by the British Journal of Sports Medicine. Researchers combed through 28 studies that included a total of more than 7,400 adults (ages 18 to 65) who used fitness trackers or apps for an average of three months. Compared with people who did not use the devices, people who did increased their activity by 1,850 steps per day. Apps and trackers that included prompts and cues to stay active appeared to be most effective. If your smartphone doesn't already have a built-in basic fitness tracker that counts your steps and calories burned, you can find an app that does. Some are free. Fancy tracking devices, with all the bells and whistles, including heart rate monitors and cellphone capability, cost as much as $1,300. But even the simplest ones help remind you to move.

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In the 1950s, doctors offered mainly morphine and bed rest — a far cry from the many procedures and medications provided today.

During a round of golf one autumn afternoon in 1955, President Dwight Eisenhower experienced what he assumed was indigestion. After he awoke at 2 a.m. the following morning with severe chest pain, his personal physician administered several shots of morphine. It wasn't until 1 p.m. that afternoon that an electrocardiogram revealed that the president had experienced a heart attack.

Cardiologist Dr. Thomas Lee, professor of medicine at Harvard Medical School, detailed Eisenhower's experience in the Oct. 29, 2020, issue of The New England Journal of Medicine. His piece focuses mainly on how Eisenhower's cardiologist, Paul Dudley White, communicated the event to the public. As Dr. Lee wrote, "Heart attacks became less mysterious and frightening to millions of Americans that day."

Learn when, how, and why you should keep track of your heartbeat.

Soon after you wake up tomorrow morning, before you even sit up in bed, take your pulse. It's fairly easy if you have a clock or timer nearby (see "Measuring your heart rate"). Known as your resting heart rate, this value ranges from 60 to 100 beats per minute in most adults.

"To get a good sense of your resting heart rate, check it every few mornings over the course of several weeks," advises cardiologist Dr. Aaron Baggish, director of the Cardiovascular Performance Program at Harvard-affiliated Massachusetts General Hospital. It's best to measure your resting heart rate when you've been getting your typical amount of sleep and exercise and aren't feeling ill or dehydrated.

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If your doctor or pharmacist offers a service to monitor blood pressure measurements you send from home (called telemonitoring), consider taking advantage of it. Past research has shown that telemonitoring — often paid for by Medicare — may help you reduce your blood pressure. And a study published online Aug. 31, 2020, by Hypertension suggests telemonitoring is also associated with a long-term reduction in heart attacks, strokes, and medical costs. The recent study is a follow-up to a randomized controlled trial from 2013 that divided 450 people into two groups: those who received routine primary care, and those who received a year of telemonitoring services with a pharmacist who helped manage their treatment. People in the telemonitoring group had lower blood pressure for up to two years afterward, compared with people who received routine care. In the recently published follow-up, which followed the same participants for five years, researchers found there were about half as many heart attacks, strokes, and hospitalizations in the telemonitoring group as there were in the group that received routine care. Because there were fewer cardiovascular problems, people in the telemonitoring group also saved an estimated $1,900 each in medical costs.

The COVID-19 pandemic has prompted a surge in telemedicine visits. Here's what you need to know about virtual health care.

Telemedicine — interactions with your doctor by video — has been slowly growing for years. But when the COVID-19 pandemic hit the United States earlier this year and forced people into isolation, this emerging form of virtual health care took off.

"In 2020, we've seen a sharp hockey stick–like movement in the number of telemedicine visits," says Dr. Joseph Kvedar, a dermatologist with Harvard-affiliated Massachusetts General Hospital and president of the American Telemedicine Association. "The experience has shown both patients and doctors the many ways telemedicine can improve health care in the current environment and beyond. It appears to be here to stay."

ECG readings taken with a smart watch may be just as accurate as a traditional ECG done in a medical setting. But the notion of using a smart watch to diagnose a heart attack is still years away. One main reason: obtaining an ECG with a smart watch requires carefully holding the back of the watch on the wrist and at eight specific locations on the chest and abdomen. Quality control and regulatory issues are other important hurdles that need to be addressed. But experts believe improved smart watches with enhanced diagnostic ability may be on the market within a decade.

Studies of drugs, diets, and devices all come with their own unique set of challenges.

The best way to know if a new medical treatment truly works is with a randomized controlled trial — the "gold standard" of research studies, also known simply as a clinical trial. Volunteers are randomly assigned to receive either the new treatment or the comparison, which may be a placebo (an inactive therapy) or a treatment that's already available.

As the nation's top cause of death, cardiovascular disease has been at the leading edge of evidence generation, says Dr. Robert Yeh, director of the Smith Center for Outcomes Research in Cardiology at Harvard-affiliated Beth Israel Deaconess Medical Center. "We probably have more evidence for cardiovascular treatments than for any other field of medicine," he says. Among the studies with the greatest impact were the clinical trials that heralded new therapies to treat heart attacks. These include clot-dissolving drugs in the 1980s, followed in the 1990s by artery-opening angioplasty procedures, which remain the standard of care today. Stents, the tiny mesh tubes used in these procedures, have also been extensively studied in clinical trials (see "Testing devices: Different dilemmas").

The modernization of standard home medical devices has made monitoring health easier than ever. These gadgets include thermometers, scales, blood pressure monitors, and pulse oximeters. Gadget features that are especially helpful for older adults are easy operation and large, lighted readouts. It’s important that some home medical devices, such as blood pressure monitors and pulse oximeters, have a seal of approval from an accredited agency, such as the FDA for pulse oximeters or the Association for the Advancement of Medical Instrumentation for blood pressure monitors.

On call

Q. Exercise guidelines recommend a certain number of hours per week, depending on whether it's moderate or vigorous intensity. So how do I measure exercise intensity?

A. Outside of a physiology laboratory, there really is no standard agreement on how people should gauge their level of exercise intensity.