Q&A: Washington hearing instrument specialist discusses FDA’s new rule that allows adults with mild hearing loss to buy hearing aids over the counter

A new FDA rule allows adults with mild to moderate hearing loss to buy hearing aids over the counter (OTC). The rule establishes a new category of hearing aids that will be sold directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.

The FDA estimates that almost 30 million US adults could benefit from the hearing aids when they hit shelves in October. The rule is expected to make hearing aids more affordable and easier to access.

Richard Giles is the Immediate Past President of the Washington Hearing Society and the Past President of the International Hearing Society. He retired in 2020, but still works occasionally at Hearing By Design, the practice he sold to Elizabeth Miller in 2020. In this Q&A, he discusses the FDA’s new rule and how it will affect the hearing aid industry.

 

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State of Reform: Millions of American adults will be able to buy hearing aids without a prescription this fall thanks to the FDA’s new rule. Have you heard customers lobby for an initiative like this? How will they benefit?

Richard Giles: “Consumers have been purchasing [Personal Sound Application Products] for many years and will frequently bring them into the office because they can’t figure out how to use them. When we notified them what they purchased was not a true hearing aid and had no regulatory protection they were often disappointed and felt they had been scammed. Some tried to return them with little success in receiving their money back. 

Our office policy has always been to discount the FDA-approved devices the amount a client had paid for them. Having a FDA-cleared OTC product that passes strict specifications will certainly help many. 

We have 2 major concerns with [the] potential benefit: first, the maximum sound pressure produced by these OTC hearing aids can cause increased noise-induced hearing loss. Prescription hearing devices sold through a licensed professional’s office have this output reduced through programming and digital signal processing. Second, the average person does not know if or how severe their hearing loss is. Many clients come in thinking they have a hearing loss and do not. Others think their loss is not [as] severe as it truly is.” 

SOR: How will the new rule affect Hearing By Design?

RG: “The rule will increase our business [in] 2 ways. First, our office will offer several different devices at different levels of quality and price points. 

We have and will continue to offer an initial consultation including a hearing screening at no charge as a community service, and if a client wishes to choose the OTC route we will recommend the best product for their individual hearing loss.”

SOR: The new class of hearing aids that don’t require a medical exam or prescription are intended for adults with mild to moderate hearing problems, while devices for more severe hearing loss will still require a prescription. The FDA estimates that nearly 30 million adults could benefit from them, but only one-fifth of people with hearing problems currently use those devices. Do you expect that number to increase with the new rule?

RG: “Market penetration in Europe, where hearing aids are free or available at a reduced cost, is 47%, [while] the US is right at 35% across all categories. People with a milder hearing loss are closer to 5% and severe hearing loss [is] approaching 60%. I am confident that individuals with mild hearing losses will purchase OTC hearing aids but without proper instruction from a licensed professional, confusion and misuse will cause many to put them in [a] drawer. 

This only benefits the retailers. They do not care whether once the products [are] purchased if [they’re] ever used. As professionals, we take great care in ensuring that a client not only knows how to use a hearing aid but also that it is correctly fit to their hearing loss, follow-up, and continue to service them for the life of the device.”

SOR: Some industry officials expect to see new manufacturers and new products on the market with the introduction of the new rule. Do you think there is a good chance of that happening?

RG: “There are already OTC hearing aids awaiting FDA 410K approval from major consumer electronics companies and I’m sure that many more will join the marketplace. Some will succeed but a large number will fail, leaving [the] consumers who purchased them without any form of service or warranty.”

This Q&A was edited for clarity and length.