Audiology’s Not-So-Scary Future With OTC Hearing Aids: Original research conducted by The Hearing Journal found that OTC hearing aids have been less impactful than originally feared.

The sale of over-the-counter (OTC) hearing aids has done little to disrupt the audiology profession, according to the overall results of a survey conducted by The Hearing Journal.www.shutterstock.com. Over-the-counter hearing aids, OTC hearing aids, audiology, self-fitting hearing aids, consumer, survey, original research.IN THEIR OWN WORDSThe U.S. Food and Drug Administration (FDA) issued its final rule1 in August 2022 authorizing the sale of OTC hearing aids, effective October 17, 2022. The Hearing Journal sought to gauge the final rule’s effects on the audiology profession by conducting a survey of its readers from May 18 through July 12 this year. The Journal sent the survey to 7,500 of its randomly chosen subscribers, and 321 subscribers, or 4%, responded. The survey’s overall results countered some practitioners’ expectations that OTCs would significantly and negatively affect the audiology profession. Regardless of OTCs, audiologists likely would benefit from analyzing their approaches to various aspects of their businesses, including prices of products, expenses for staff, potential assignment of non-billable services to an office assistant, and whether to unbundle their services. In its final rule, the FDA states that the rule “to establish OTC hearing aids and align other regulations generates potential cost savings for consumers with perceived mild to moderate hearing impairment who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance but who are currently unable to buy such products online because of State regulations or because they do not shop online.” The final rule required hearing aid manufacturers to incur costs to change labels on existing hearing aids and amend their internal standard operating procedures. But the FDA says it wants the final rule to protect and advance public health regarding hearing health care. “In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health,” the final rule states. The survey addressed four main areas: patient volume; pricing, products, and services; self-fitting; and changing business practices. Here are some highlights from the study results. PATIENT VOLUME Three-quarters of respondents said their volume of patients did not change when OTC hearing aids became available. Seven out of 10 respondents said the volume of new--patient appointments did not change. About two-fifths of respondents said that in the prior six months they had patients who needed help fitting OTC hearing aids they had purchased. This leaves room for audiologists to explore expanding their services to this category of consumers. PRICING, PRODUCTS, AND SERVICES Overall, 72% of respondents saw no revenue change since the advent of OTCs; 17% saw decreased revenue; and 11% saw increased revenue. Among large group practices, 77% saw no change in revenue. Among private practices, 61% saw no change. Among small group practices, 68% saw no change. Half of respondents had more patients ask about OTC hearing aid options. One-fifth of respondents had more patients ask about personal sound amplification products (PSAPs) and hearables. About one out of six respondents had increased the price of their hearing aids. Private practices were most likely to increase their price of and unbundle their pricing for hearing aids. Small group practices were most likely to decrease their price for hearing aids. Seven out of 10 respondents didn’t offer PSAPs or hearables and didn’t plan to offer them. Almost one out of 10 respondents offered PSAPs or hearables. About one-quarter of respondents supported hearing aid manufacturers by offering their OTC aid with their traditional aids. SELF-FITTING Almost nine out of 10 respondents agreed that patients should consult professional hearing services for OTCs. Almost three-quarters agreed that self-fitting with OTCs increased health risks. About 98% of respondents do not believe self-fitting has improved satisfaction rates with patients or that hearing technology has evolved enough for effective patient self-fitting. CHANGING BUSINESS PRACTICES Most respondents had made no changes to their practice. The most common changes were increased service fees and traditional hearing aid prices. One out of 10 respondents had increased their spending on marketing and advertising. Audiology practices generally had made no staffing changes since OTC hearing aids became available. Small group practices were most likely to hire an audiologist assistant. Large group practices were most likely to hire an audiologist. Nearly half of respondents believed OTC hearing aid availability had enabled greater access to hearing aid technology. About one-quarter of respondents did not believe OTCs had enabled greater access. TRENDING INDUSTRY CHANGES Stephanie Czuhajewski, executive director of the Academy of Doctors of Audiology, and Jason Leyendecker, AuD, the ADA’s president-elect, said it was too soon after the FDA’s final rule went into effect to know whether OTCs would significantly affect the profession. Leyendecker owns Audiology Concepts, an audiology practice based in Edina, Minnesota, with six other locations in the state. Both Czuhajewski and Leyendecker said they had found none of the survey’s results surprising. Leyendecker said that patients had frequently asked questions about OTCs after the final rule went into effect but that they had begun asking fewer questions about OTCs. He now raises the subject with his patients more often than they do with him. The ADA encourages people to get diagnostic testing from an audiologist before buying an OTC, Czuhajewski said. Because the devices are sold over the counter, “we’re not necessarily surprised if people choose not to do that.” Leyendecker said based on inflation and the cost of goods rising, prices for his products and services were more often rising than falling. He expects more audiologists will unbundle their services in light of OTCs. These services include programming and cleaning devices, counseling, and Bluetooth pairing. Unbundling services can better serve patients and enable audiologists to ensure “we’re showing our value with every hour of our time we spend with our patient, so the patient really understands what they’re getting on our end as a provider,” he said. “That’s what I would see as a general trend across our industry,” Leyendecker said. “Now the clinician and patient are seeing the value of their time. It’s transparency.” Some audiologists are adding different services such as auditory training for people who don’t necessarily need to wear a hearing aid all the time, Czuhajewski said. This could help them prepare to get hearing health care sooner because they have bought OTC hearing aids and then seek services from an audiologist, which they might not have otherwise. “OTCs have raised awareness about hearing health,” she said. “Audiologists are wanting to incorporate more services. It’s important to understand that OTC hearing aids are no less hearing aids than the prescription hearing aids. With the FDA requirements, they are pretty rigorous.” Leyendecker sees the FDA’s final rule on OTCs as beneficial for self-fitting “because these products have been available before but they were not regulated.” “Now there’s a requirement for certain standards for these products, so if somebody is going to buy them OTC, at least they’ll know it’s going to do its job and hopefully be safer,” he said. GROWING AWARENESS OF HEARING HEALTH CARE It’s too early for audiologists to conclude how OTC availability will affect the accessibility of hearing aid technology, Czuhajewski said. The ADA has always supported having OTC hearing aids available because it would lessen the stigma often associated with hearing aids and other barriers people face to getting the devices. “Our hope would be it would increase awareness of and intervention for hearing loss,” she said. Leyendecker cited a recent example of that. A homebound, elderly patient called him because she needed new devices. He could hear her television in the background on the phone because she had the volume so loud. “We talked through some of the OTC products,” he said. “I counseled her about having a return policy. And we have a lot of rural patients in northern Minnesota. They may drive two hours to get to a main city, and they don’t have access to that care often.” Audiologists, of course, want everyone who needs hearing health care to have access to it. The ADA members Czuhajewski talks to don’t see the advent of OTCs “at all with trepidation at this point.” OTHER INDUSTRY NEEDS “If we’re thinking about hearing health as a public health consideration, then we need to be open to getting people into hearing health care on their own terms in some ways and being there as a resource and a partner and a professional to guide them,” she said. “I think there are many other things that audiologists look at that have a bigger impact on the profession itself. One of those challenges is workforce. In a lot of cases, we’re not making enough audiologists fast enough to keep up with the need.” Insufficient insurance coverage for hearing health care services and hearing aids broadly also poses a problem, Czuhajewski said, adding that “OTC was born from a very real need that existed for people whether it’s stigma, access or cost.” Hearing aids themselves are important, but they are only one part of a treatment plan audiologists provide, she said. A plan’s other components also need to be covered, whether through commercial insurance plans or Medicare. Medicare might cover parts of those services but doesn’t recognize audiologists appropriately. “Most older adults have a very difficult time getting care from an audiologist,” Czuhajewski said. “We’ve been working on legislation that would improve that as it relates to the services.” U.S. Senators Chuck Grassley (R-Iowa), Elizabeth Warren (D-Mass.), and Rand Paul (R-Ky.) recently introduced the Medicare Audiology Access Improvement Act.2 Czuhajewski said the proposed legislation would give Medicare beneficiaries better access to audiology services by eliminating some red tape of having to get a pre-treatment order. It would reimburse audiologists for Medicare coverage services they are licensed to provide. And it would reclassify audiologists from suppliers to practitioners, which would authorize them to deliver services via telehealth, among other things. “There wouldn’t be a need for OTCs if the broader access to care were being addressed,” she said. “There’s also a lot more data today that points to the importance of early intervention when it comes to hearing and balance conditions. Hearing loss is linked to falls and cognitive decline and other things that really cost the system a lot of money.” IN THEIR OWN WORDS The following are some of the survey respondents’ answers to open-ended questions about OTCs’ likely effects on the profession: “As a doctor of audiology, I strongly disagree with over-the-counter hearing aids. I have a firm belief that these type of hearing aids will never put either audiologists (or doctors of audiology) out of business. Simply because the product (which contains inferior technology) is available to the public does not mean that they will understand how to adjust it appropriately, which is what I have found in my practice. In fact, I believe OTC hearing aids have created even more confusion about the science of hearing and balance. At this stage, I believe the public absolutely still needs specialists like audiologists in order to make any product effective. Bottom line: OTC hearing aids are having a very strong negative impact on our field.” “I think that audiologists can see OTC as an opportunity rather than a hinderance. We should be marketing ourselves to these OTC companies to act as consultants and to offer to support those who purchase their products with diagnostic hearing testing, consultation, and additional support.” “I can only speak for my city, but we have had no noticeable impact from OTC, and with all the talk about recession I think it would be hard to separate any decrease in demand from financial concerns. Also, many of my very sophisticated tech users have tried to self-program OTC aids and not found the programming anywhere near as good as that done in the office.” Thoughts on something you read here? Write to us at [email protected].