Auditory Insight Assesses Impact of FDA Proposal for OTC Hearing Aids

New FDA proposed rule will apply to a broad segment of people with hearing loss

New Haven, CTAuditory Insight, a leading consultancy for the hearing healthcare industry, analyzes the impact of the FDA's recently proposed rule for over-the-counter (OTC) hearing aids in a special research bulletin.

Download the research commentary: New FDA Proposal for OTC Hearing Aids

The Over-the-Counter Hearing Aid act, passed in 2017, directs the FDA to create a new category for self-fit hearing aids—requiring no intervention from a licensed professional—for people over 18 with mild to moderate hearing loss. In its proposed rule, the FDA embraces the spirit of the legislation by stipulating a meaningful maximum output limit (the loudest sound the hearing aid can deliver).

"The proposed rule should ensure that OTC hearing aids can perform well for not only people with mild hearing loss, but also for those with moderate loss. The potential market for OTC hearing aids would apply to the majority of people with hearing difficulties," asserts Nancy M. Williams, president of Auditory Insight. "Consumers with hearing loss should benefit greatly from the new OTC hearing aid category."

Auditory Insight's commentary details three types of companies that have the resources to capitalize on the proposed rule to compete in the new OTC category:

  • Powerhouse consumer brand companies like Apple, Bose, and Costco
  • Start-up innovators in both product and service delivery
  • Payers, especially Medicare Advantage payers and United Healthcare.

"We expect to see innovation in product design and service delivery, as well as considerably lower prices of around $500 on average for a pair of OTC hearing aids," says Williams. "That's a tenth of today's $5,500 for a pair of traditional hearing aids from an audiology or ENT clinic."

Auditory Insight has published on its website a series of research notes describing key strategic commercial issues in hearing healthcare, with topics such as addressing stigma, understanding Apple's role, and evaluating the quality of telehealth hearing care.

Williams is available to discuss this research and the impact of the FDA's proposed rule for OTC hearing aids.

About Auditory Insight

Auditory Insight partners with senior leaders of hearing health device and pharmaceutical companies to develop successful commercialization strategies. The firm also advises growth equity and private equity funds on creating portfolio value in hearing healthcare.