FDA’s decision to permit the sale of over-the-counter hearing aids has the potential to create “a broader shift in the global hearing-aid market,” but only if other countries consider similar regulatory changes and take “additional steps to increase consumer access to hearing technologies and services,” write authors of a Perspective article. “The United States is the first country to have a regulated market for OTC hearing aids, and whether other countries follow suit will depend on each country’s internal stakeholders and regulatory policies. Such efforts will require concerted and coordinated action by policymakers and hearing-health advocates in various countries to overcome inertia and move beyond the status quo of a historical model for hearing-care delivery that no longer meets the needs of the public.”
FDA’s action likely launches a “period of profound disruption in the design, marketing, and sale of hearing aids in the United States and possibly the world,” the authors write. “But challenges remain when it comes to achieving the broader goal of creating a hearing-care market that best serves the needs of the public.” Strategies will be needed for translating consumer hearing-care needs into demand for hearing services and technologies, people must have access to audiologists and other professionals who can guide the patient’s purchasing decision, and consumers will need to recognize that OTC hearing aids are appropriate only for those with mild-to-moderate hearing loss.