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FDA approves over-the-counter hearing aid from Bose The US Food and Drug Administration has, for the first time, approved a hearing aid that can be fit, programmed and controlled by the user instead of a healthcare provider. The device comes from Bose and users can make adjustments to its settings in real time through a mobile app. "Hearing loss is a significant public health issue, especially as individuals age," said Malvina Eydelman, director of the

Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. "Today's marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with

hearing loss have options for taking an active role in their health care." This new usercontrolled hearing aid was made possible through a law passed last yearthat appr oved over the-counter hearing aids. It aims to provide adults with mild to moderate hearing loss access to hearing aids without them having to go through a physician first. The FDA says around 37.5

million adults report hearing loss ranging from "a little trouble" to "deaf." Though they're not approved by the FDA as hearing aids, a number of companies have developed wireless earbuds that can manipulate and augment sound. Bose, Nuheara and the now defunctDoppler Labs have all released assistive hearing devices in the past.

Statins' benefits beyond heart health aren't clear-cut, analysis says Despite some studies suggesting that statin drugs have benefits beyond cardiovascular health, for such issues as cancer and Alzheimer's, a broad new analysis says there's a lack of compelling evidence linking such benefits to statins -- and, thus, little reason to change recommendations for who gets these cholesterol-lowering meds and why. The drugs are commonly prescribed to prevent heart disease in individuals above a certain risk level, but the new analysis -- published Monday in the journal Annals of Internal Medicine -- looked at 278 other health conditions and effects. "I was surprised by the amount of outcomes we identified to have been linked with statins," study author

Evropi Theodoratou, a researcher at the University of Edinburgh, wrote in an email. "However, we only identified a dearth of convincing evidence that statins had a major role" in these outcomes. The analysis found limited evidence of positive outcomes related to cancer, dementia, kidney disease and chronic obstructive pulmonary disease, known as COPD. But only one of these outcomes was significant in a randomized trial -- lower all-cause mortality in patients with chronic kidney disease -- and the authors say it could still be driven by the drugs' impact on cardiovascular disease; the two often go hand in hand. "Clinical guidelines already

recognize the benefits of statins in preventing cardiovascular events in patients with chronic kidney disease who are not receiving dialysis. On the other hand, clinical guidelines currently do not indicate the use of statins to improve cancer prognosis or COPD," Theodoratou said. "I am not aware of any serious efforts by doctors to redefine these guidelines." More testing needed More than a quarter of Americans over 40 take a statin, the most common type of cholesterol-lowering medication, according to a 2014 report from the US Centers for Disease Control and Prevention. Different statins are sold under brand names such as Lipitor and

Crestor. Michael Pencina, vice dean for data science and information technology at the Duke University School of Medicine, said the analysis was important because people will invariably be on statins for long periods of time for their heart health, but the question remains: What else could those statins be doing, good or bad? "I think what we are generally missing in the whole statin discussion is the fully integrated risk-benefit analysis," said Pencina, who was not involved in the new study. Researchers say this doesn't mean these outcomes aren't necessarily null; they just haven't been sufficiently tested yet….Read More

Seniors, Take Steps to Reduce Your Risk of Falling One in four Americans 65 and older falls each year, with some ending up in hospitals or even dying. But new research suggests that it's possible to avoid some of these serious injuries. When seniors who are at risk of falling have a prevention plan, they're less likely to suffer a tumble-related hospitalization, the study found. "We saw statistically significant change that reduced

fall risk in people at risk of falls to almost the same as those who weren't at risk of a fall [at the start of the study]," said the study's lead author, Yvonne Johnston, an associate professor at the Binghamton University School of Nursing in New York. "Considering the cost of one hospitalization for fall, avoiding just one hospitalization compared to the cost of the

program makes it a worthwhile program," she noted. In 2014, 29 million older adults reported a fall, and 7 million of those resulted in an injury, according to the study. Johnston said that many falls go unreported, so these numbers may underestimate the extent of the problem. In 2016, falls were responsible for 29,000 deaths in the United

States, the study authors said. Medical costs related to falls may be as much as $50 billion. The current study looked at a U.S. Centers for Disease Control and Prevention fall prevention initiative. It included screening to identify older people who are at risk of falling. This assessment looked at vision problems, low blood pressure, medications, home hazards and functional ability such as leg strength….Read More

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RI ARA October 14, 2018 E-Newsletter  

RI ARA October 14, 2018 E-Newsletter  

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