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Problematic as it is, the hearing aid business model has remained more or less the same since the FDA classified hearing aids as medical devices in 1977. Before then, hearing aids were generally treated as a consumer product, with some hilariously bad and misleading advertising and celebrity endorsements to go along with that positioning. Meanwhile, in-ear hearing aids—which needed to be fitted to individuals' ears—were often sold by audiologists, and that became the norm. Due in part to misleading claims and some shoddy practices, interest groups began to raise alarms about hearing aids, prompting the FDA to classify them as medical devices with extremely strict protocols for their manufacture and dispensing.

The current inflection point for the highly regulated (and profitable) hearing aid business had its roots in two citizen petitions filed with the FDA in 2003. An FDA citizen petition is a process that was originally intended to allow individuals and community organizations to make requests for changes to healthcare policy. While the petitions themselves had no immediate impact on the way hearing aids were regulated, they were early markers of a shift in sentiment that would move these devices toward the same over-the-counter access currently available for "reading glasses"—corrective lenses that can be sold without a prescription.

The incumbents aren't eager to back down. No less than the American Academy of Audiology suggests that any device that amplifies sound should be subject to FDA regulation. Taken literally, this position could be seen as requiring such regulation for everything from earbuds to headsets.

The academy aside, the cost to consumers and the intransigence of incumbents have led to an odd coalition of bedfellows determined to change the system. In 2017, for the first time, the regulatory structure that the academy has been trying so hard to preserve began to be dismantled. In a classic Clay Christensenstyle disruption, new technologies are proving to be "good enough" and are expanding the pool of consumers who might benefit from an improved ability to hear. This is what Christensen has often described as "competing with non-use."


Although they are not—heavens no, absolutely not—selling hearing aids, there is no shortage of companies offering what in the industry are called "personal sound amplification products," or PSAPs. These products are not regulated by the FDA and are readily available over the counter to anyone who wants them. And even more worrisome to the conventional hearing aid manufacturers, in many hearing assistance applications, PSAPs do just as well—or even better.

For instance, Bose, the iconic manufacturer of speakers and noise-canceling headphones, is making a product it calls Hearphones that sell for around $500. Despite advertising that makes it sound an awful lot like the product is directed at people suffering from hearing loss ("We want to help you hear every word of your conversations"), at one point, Bose was emphatic that these devices were most definitely not hearing aids, thus avoiding FDA oversight. In 2018, however, the company received approval for an over-the-counter version of a self-fitting hearing aid. Other heavyweight players are crowding into the market, including Samsung with its Gear IconX earbuds and Apple with its AirPods—wireless earphones that can allow you to listen to music, time exercises, and, incidentally, connect to hearing aid apps on a phone or other device. In addition, dozens of new companies are piling into the aid space, with aids like Fennex, Petralex, and Here One. And on the startup side of things, a product called Eargo took its inspiration from fly fishing to create an actual hearing aid that you fit yourself, buy over the Internet, and charge the way you might charge one of your more familiar electronic devices.

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