As FDA rule takes effect, Lucid Hearing launches over-the-counter line of hearing aids

Monday marked the first day that some hearing aids may be sold over the counter, without requiring any prescriptions, hearing tests or fitting appointments, thanks to a recently finalized—and long-awaited—ruling from the FDA.

Among those taking advantage of the new OTC opportunity was Lucid Hearing, which joined several other devicemakers in rolling out a brand-new line of hearing aids Oct 17.

Lucid’s over-the-counter collection so far includes four types of hearing aids that not only offer a variety of fit, style and battery options but also cater to a range of budgets. Beginning this week, many of the devices will be available for purchase from Sam’s Club, Amazon and several other retailers as well as through Lucid’s website.

The most basic of Lucid’s new offerings is the Enrich behind-the-ear hearing aid, which comes in both a battery-powered option for about $200 and a rechargeable model priced near $300. It arrives equipped with three preset hearing programs that aim to support the majority of users’ mild to moderate hearing issues, according to Bennett Griffin, Lucid’s executive vice president of research and development.

At the other end of the spectrum is the in-ear Fio system. It boasts a rechargeable battery that can last up to 16 hours on a single charge, and its audio settings can be controlled and adjusted entirely via an accompanying app. The system retails for about $1,700—still at the lower end of the average price of a prescription hearing aid, which start around $1,300 on Lucid’s own site.

All of the new additions to the Fort Worth, Texas-based company’s portfolio were developed using the results of a study of more than 90,000 audiograms in partnership with audiology researchers from the University of Texas at Dallas.

Though hearing and fitting tests aren’t required for the new OTC options, Lucid will continue to offer free hearing exams through its more than 500 hearing aid centers, most of which are located inside Sam’s Club stores. The test’s results can be helpful in both tracking hearing health over time and in choosing the most effective hearing aid option for each patient’s needs.

In keeping with the parameters of the FDA’s new rule, hearing aids can only be sold over the counter to people who are 18 and older and have mild to moderate hearing loss, while children and those with severe hearing loss will still require a prescription to purchase a hearing device.

Approximately 38 million Americans fall into those eligibility criteria, but just 20% are actually using hearing aids, according to estimates cited by the FDA, which has heralded the new rule’s potential to improve access to and affordability of hearing aids for that group.

In addition to Lucid, several other companies are racing to fill that gap with OTC offerings of their own. Last week, both Sony and Lexie Hearing introduced their first products in the category, which include both battery-powered and rechargeable options, smartphone app connectivity and prices starting at $999.