![]() It wasn’t until July 2021 that an executive order reinvigorated the process, giving the FDA 120 days to publish the suggested legal framework.įollowing that executive order, the FDA formally proposed rules to establish the new OTC hearing aids category in October 2021. As a result, the deadline of August 2020 lapsed without the required guidelines in place. According to Barbara Kelley, executive director of the Hearing Loss Association of America, the process was likely stymied by the formalities of red tape combined with an FDA focused on the pandemic. The sale of OTC hearing aids seemed to be close at hand.Īnd then … not much happened. As long as a hearing device met these standards, it could be sold as a hearing aid directly to the people who wear them, instead of through an audiologist. These guidelines would establish directives for aspects such as device effectiveness, safety, and labeling, as well as where and how over-the-counter hearing aids could be sold. When FDARA passed in 2017, the law stipulated that the FDA was to present proposed regulation for this new industry not later than three years (PDF) after enactment. Proponents of the law, such as the Consumer Healthcare Products Association, say that OTC hearing aids will improve access and lower costs, resulting in a benefit to both patients and the healthcare system. The law directed the Food and Drug Administration to create a category of over-the-counter hearing aids that adults with perceived mild to moderate hearing loss could set up, tune, and adjust on their own. ![]() Many people simply cannot manage to get to and from all these appointments with regularity.Ī law called the FDA Reauthorization Act of 2017 (or FDARA) aimed to address these concerns. The initial testing and tuning of the hearing aids may require multiple trips to the audiologist, and the devices generally need to be rechecked at least annually (some audiologists recommend a recheck every six months, though that advice varies). Patients are currently required to see a licensed hearing professional and obtain a prescription prior to purchasing hearing aids. ![]() This cost burden is especially challenging for someone on a fixed income.Įven if money isn’t an issue, access to audiologists can pose another obstacle. Making matters worse, hearing aids have an average lifespan of just five to six years, which means that a person diagnosed with hearing loss in their mid-50s can expect to purchase multiple pairs over their lifetime. In fact, the original 1965 Medicare Act (PDF) specifically excluded coverage of hearing aids-a quirk of the law that hasn’t changed. Medicare doesn’t cover hearing aids at all. Traditional hearing aids range in price from around $1,000 to over $14,000 per pair, and most insurance plans offer only partial coverage. Let’s see if we can help clear up some things. The bad news: Right now there’s a lot of confusion surrounding these devices, involving the slow-moving legislation that made them possible, where they can be sold, and even what they can be called. The good news: Lower-priced over-the-counter hearing aids are coming, and many of them won’t be much bigger than a true wireless earbud. Hearing aids are expensive, getting them can be inconvenient, and wearing them can feel stigmatizing. Nearly 86% of Americans over 50 who have hearing loss don’t wear hearing aids, according to a study conducted between 19 and published in the journal Archives of Internal Medicine. It’s easy to understand why.
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