Six companies dominate the worldwide market for traditional hearing aids, with their collective share of the U.S. market over 95 percent. At the AAA 2018 conference earlier this year, senior executives from three of these market leaders—Starkey Hearing Technologies, Sonova Holding AG, and Widex A/S—discussed their planned response to forthcoming OTC deregulation in interviews at the event. (Disclosure: My company has consulted for Sonova on comorbidities with hearing loss.)

Healthcare categories transforming to OTC generally benefit when companies with deep pockets and direct-to-consumer marketing expertise invest in market development. These investments create awareness of the new OTC category among both medical and consumer communities and catalyze adoption of the category.

Although the FDA has until early 2021 to publish final guidelines for OTC hearing aids, the regulator may do this as early as the middle of 2019, according to Brian Taylor, editor of Audiology Practices.

Once the FDA finalizes guidelines, the six global hearing aid companies will face a trajectory familiar to other sectors that have shifted to OTC in the past. They will likely confront dramatically lower prices but also the opportunity to develop the larger market—the 85 percent of consumers who would benefit from amplification but currently don’t wear aids.