In August, President Trump signed The Over-the-Counter (OTC) Hearing Aid Act of 2017 in to law as part of the Food and Drug Administration (FDA) Reauthorization Act of 2017. Sen. Elizabeth Warren (D-Mass.) a cosponsor of the bill, said, “By passing this legislation and making some hearing aids available over the counter, we will increase competition, spur innovation, and bring down prices.”
James C. Denneny III, MD, executive vice president and CEO of the American Academy of Otolaryngology–Head and Neck Surgery (AAO–HNS), agreed. “OTC access has a high likelihood of affecting pricing,” he said. “Pricing will be more transparent, and it is anticipated that competition within the market will lower the cost of hearing aids, particularly ‘entry-level’ hearing aids appropriate for mild-to-moderate sensorineural hearing loss.”
Cutting the cost of hearing aids to make them more accessible is the clear benefit of this new law. How this will affect otolaryngologists and audiologists is, of course, still largely unknown as details of the law are not yet final. However, Dr. Denneny and others here weigh in on the effects this new law may have on clinical practice.
Accessibility and Affordability
One primary benefit of OTC hearing aids, according to Dr. Denneny, is the expectation that easier accessibility to the devices will lower some of the barriers for patients who need care for hearing loss. “The biggest benefit of this legislation will likely be the increased participation of patients who previously had chosen not to access the system and will now have their hearing evaluated,” he said. “A likely result of this will be the identification of hearing loss at an earlier stage and initiating treatment for many who would not otherwise do so.”
Lauren Mann, an audiologist and clinical coordinator for audiology at the University of Kansas Medical Center in Kansas City, said that identifying more patients with hearing loss may allow for earlier detection of underlying medical conditions. In addition, she said that wider identification of patients with hearing loss will benefit research and promote further understanding of the effects of hearing loss, such as cognitive decline. “I think there’s still so much we don’t know and could start to learn with the onslaught of patients seeking amplification sooner through OTC options,” she added.
Bruce J. Gantz, MD, professor and head of the department of otolaryngology–head and neck surgery at the University of Iowa in Iowa City, agreed, but with a slight caveat. While he said that the availability of OTC hearing aids may lead to increases in identifying people with hearing loss, he also suggested that part of this increased identification may come from people who buy the OTC devices and eventually visit an otolaryngologist or audiologist because they are unhappy with them.
Dr. Gantz emphasized that basic questions about OTC devices, such as whether patients will need to visit an audiologist or otolaryngologist and who will fit the devices, remain unanswered.
Concerns
One clear shared concern among otolaryngologists and audiologist is the safety of offering OTC hearing aids without a clinical examination and diagnosis. “The main concerns expressed to date by the AAO–HNS center around patient inexperience in navigating a new system that could lead to inaccurate diagnoses and inappropriate use of hearing aids,” said Dr. Denneny.
Until specifics of the law are known there is little information on how the devices will be fitted. Dr. Denneny said that ill-fitting hearing aids can cause irritation and possible damage to the external auditory canal and even the ear drum. “Along with significant discomfort, improperly fitted hearing aids also cause ‘squealing’ sounds that discourage regular usage,” he added.
Another safety concern raised by Mann is the potential use of OTC hearing aids in children. Although the law is centered on providing OTC hearing aids for patients at least 18 years of age, she worries that parents may purchase them for their children. “That’s a great concern, given the importance of access to speech sounds during development and a host of potential issues that could arise when it comes to children,” she said. She added that it will be important to ensure that specifications for the devices be tailored only for adults and for mild hearing loss.
Dr. Denneny also emphasized that OTC hearing aids are not appropriate for children. “The AAO–HNS feels it is essential that pediatric patients have access to complete examination, accurate diagnoses, and proper fitting of the appropriate medical device for their type of hearing loss,” he said. “The consequences of not identifying and treating hearing loss in the pediatric patient have a negative impact that often lasts throughout their lifetime.”
Opportunity for Education
The FDA is taxed with providing details of this new law over the next three years. Until then, Mann said that passage of the law is an important first step to starting the conversation on the importance of hearing loss and barriers to access. “We’ve long known the typical delay from hearing loss identification to intervention can be upward of seven years,” she said. “This is an opportunity to start thinking about hearing loss sooner.”
Mann also thinks that the law opens up an even greater opportunity for audiologists to participate in the care of patients with hearing loss. “The audiologist is an important part of the process, since we have the knowledge and capacity to help patients safely select OTC hearing aids, orient them to their use and care, and troubleshoot when something goes wrong,” she said.
Dr. Denneny said that the OTC availability also allows an opportunity for more patient education on hearing loss, and the Academy is already preparing education materials to help patients navigate the system. He also encouraged otolaryngologists to be prepared to act as advocates for patient safety and appropriate treatment as these regulations are created.