In August 2022, the US Food and Drug Administration (FDA) finalized its historic ruling outlining a nonprescription over-the-counter (OTC) hearing aid category. The ruling aims to offer you more options at lower costs by relaxing regulations surrounding the development and sales of hearing aids. Since then, new products have emerged weekly, claiming to offer a “prescription-like” quality for a fractional cost of traditional clinical hearing care. Many of these devices are available online and in-store at consumer electronics retailers such as BestBuy, Walgreens, and Walmart (the focus of this article).
While the FDA rolled-back many regulations, they have established guidelines for OTC products and their performance. For example, OTC hearing aids are intended for individuals over 18 with no worse than a mild-to-moderate perceived hearing loss and they have general output limits of 111 decibels (higher for devices utilizing input compression).
The FDA regulations have several direct consequences for consumers, including less consumer protection for trial periods, warranties, and return policies. There remains much debate about whether the current regulations are enough to protect consumers from unsafe, ineffective, and low-quality products that reach store shelves or that can be purchased online.
If you are among the over 30-million adults in the U.S. with untreated hearing loss, you may be asking “Do OTC products deliver comparable hearing benefit at lower-costs?” In my experience, after hands-on testing of over 60 modern products, the answer is a resounding no. The scientific testing I do through HearAdvisor has convinced me that while the current regulations are a good start, they are a far cry from appropriate quality assurance and consumer protection.
Some devices do offer excellent value, fulfilling the original goal of OTC products, while others can potentially worsen your ability to understand speech. Worse yet, all devices tend to share the same marketing claims to: 1) make speech clear and 2) help you in background noise. How can you dig through the advertisements and find a quality product? Without trying to sound too idealistic, that is why HearingTracker and HearAdvisor have teamed up to offer reviews such as this one.
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