What You Need to Know about Over-the-Counter Hearing Aids

By Shelby Deering

While some health concerns can be addressed with a quick trip to your local pharmacy, others can be a lot more complicated and costly. For several years, hearing aids have fallen into this category, priced anywhere from $900 all the way up to $6,000 or more. Improved hearing has a direct effect on a person’s quality of life, so people have begrudgingly footed the bill — that is, until now. Last August, the FDA approved the use of over-the-counter hearing aids for certain cases in which people experience hearing loss, making these adaptive aids more affordable and accessible than ever.

According to Anthony Florek, president of Soundwave Hearing, LLC, an Oak Brook, Illinois-based company that’s on the cutting edge of this movement, these new over-the-counter hearing aids are intended for people over the age of 18 with mild-to-moderate hearing loss. The new rules don’t require a hearing exam or prescription, and they’re regulated by the FDA as a separate category from traditional prescription hearing aids.

“The new FDA regulations governing over-the-counter hearing aids ensure that [they] will be safe and effective,” Florek says. “In addition to specifying maximum volume levels, insertion depth and labeling requirements, the regulations also describe the requirements for buying hearing aids without a prescription via mail, in person and online.”

It’s a far cry from the process people have typically gone through to attain hearing aids. As Paul G. Rudkin, Au.D. of Janesville’s Mercyhealth system explains, historically, hearing-impaired individuals would see an audiologist for a hearing exam and consultation, and a hearing aid would be selected based upon the patient’s preferences and needs. Once the appropriate hearing aid was chosen and ordered, a fitting appointment would be scheduled at a later date to allow the audiologist to program the hearing aids and discuss care and maintenance. Two weeks after the initial fitting, the patient would return for a follow-up visit for additional adjustments and to discuss any concerns.

With the new over-the-counter model, customers won’t need to go through any of these steps and will be able to complete the adjustments and maintenance themselves at home. Because of this, the price for over-the-counter hearing aids is significantly lower than traditional equipment. On average, over-the- counter hearing aids run about $300 to $500, which is music to the ears of many who previously believed they would need to shell out thousands of dollars for a set.

Dr. Rudkin explains that the benefits to the new, over-the-counter hearing aids include this lower price point as well as the elimination of time- consuming hearing aid fittings and follow-up care. He adds that most over-the-counter hearing aids are likely to be the over-the-ear style that has become popular over the last decade. “There are some in- the-ear (ITE) type aids that are also available,” he explains. “However, they are not custom-made and may not fit well.”

You might be wondering how to set up your over-the-counter hearing aids once you’ve bought them. Florek of Soundwave Hearing explains that you can order their hearing aids online from the “comfort of your home.” Customers then download a free app to their smartphone in order to take a three-minute hearing test using the newly purchased hearing aids. The app automatically customizes the new equipment to the individual’s hearing needs, and customers can further personalize their preferred hearing levels within the app.

Over-the-counter hearing aids can be purchased directly from pharmacies, big-box stores or online. Importantly, Dr. Rudkin points out that these new hearing aids may not work for all cases of hearing loss. “The most important thing is that over-the-counter hearing aids are not for everybody,” he explains. “They may work well for individuals who have a typical, mild-to-moderate, high- frequency hearing loss due to aging or loud noise exposure. However, all hearing losses are not the same, and if the hearing aids are not programmed specifically to the consumer’s needs, they may not hear as well with an over-the-counter device as they would with a conventional hearing aid.” That said, for the right person, the new technology may allow for easier interaction and improved quality of life, at a much more affordable price point than has ever been available.

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