The Food and Drug Administration recently approved regulations that will allow hearing aids to be sold without a prescription as early as this fall, a move intended to broaden access to the devices, which only a fraction of the millions of Americans with hearing loss today have. use today. The Gazette spoke to Meaghan Reed, director of clinical audiology at Harvard-affiliated Massachusetts Eye and Ear Infirmary, about the decision. She said experts hope it will cut costs, increase innovation and expand access. The interview has been edited for clarity and length.
GAZETTE: What was your response to the news?
REED: It’s a good decision. It went on for five or six years, and I’m glad the FDA finalized those regulations.
GAZETTE: What motivated the decision?
REED: There are approximately 30 million people in the United States with hearing loss and only a small percentage of individuals who could benefit from hearing aids actually pursue them. We also know that it takes people a while, once they start having hearing difficulties, to continue with the intervention — about seven years on average.
The National Academies of Sciences, Engineering, and Medicine convened a group in 2016 to examine accessibility and affordability of hearing loss and hearing health care. One of their recommendations was that the FDA create this class of over-the-counter hearing aids to overcome some of the barriers that prevent individuals from pursuing hearing intervention when they could benefit from it. The affordability of hearing aids is certainly one such issue. Accessibility can be another barrier.
GAZETTE: How much does a hearing aid cost and is part of the cost covered by insurance?
REED: The average cost is $2,000 to $5,000. Manufacturers are blamed a lot because these devices are expensive – and they are more expensive than they should be. The idea is that over-the-counter hearing aids could bring more vendors into the market and that could drive costs down. But another thing that contributes to the cost of hearing aids is the fees associated with hearing health professionals – an audiologist or hearing aid specialist – who fit and dispense and provide the long-term care to support these devices. Our services are often built into this cost.
Unfortunately, Medicare doesn’t cover hearing aids, so older people who have hearing loss — which is the largest patient population — may not be covered if their only insurance is Medicare. More commercial insurance is starting to provide some coverage, but it’s often not for the full cost of the device. There aren’t many insurance plans that offer full coverage for hearing aids.
GAZETTE: What are the main causes of hearing loss?
REED: Presbycusis, age-related hearing loss, is the leading cause of hearing loss. Added to this are environmental factors. Although there is more awareness and education in the workplace for the harmful effects of noise exposure and when to use hearing protection, compliance may not always be met. And there has been an increase in exposure to environmental noise – the world is a much noisier place than it was 20 or 30 years ago.
GAZETTE: What is the impact of hearing loss on quality of life and the ability to live independently?
REED: It depends on the degree of hearing loss and the communication needs of the individual. Mild to moderate hearing loss is usually not severe enough to impact one-on-one conversation in a quiet situation, but it can be debilitating in complicated listening situations – restaurants or social gatherings with lots of people. ambient background noise, or multiple people speaking simultaneously, or situations where speakers are at a distance and may have soft voices. This is where this degree of hearing loss will have the most impact. Regardless of the degree, hearing loss can be very isolating. Depression is associated with hearing loss and it is very easy to imagine, for someone who does not feel comfortable in social situations, that engaging in life becomes increasingly internalized and isolated. , which may confound other factors.
GAZETTE: What effects do you expect from over-the-counter sales?
REED: I hope there will be better regulation of over-the-counter devices. Previously, there was separate regulation for “personal sound amplifiers”, a less expensive over-the-counter option that provides amplification. These are not intended to be advertised for the hearing impaired, although many of these devices have similar features and functionality to hearing aids. But the quality of these devices is extremely variable. My hope with these regulations is that over-the-counter hearing aids will be better regulated and provide a higher standard quality device, and that we can be confident in their safety and effectiveness.
GAZETTE: Are the new rules expected to stimulate innovation and the entry of new companies into the market?
REED: Yes. I can’t wait to see what kinds of devices might be coming. When we talk about barriers, accessibility and affordability are not the only ones, there is always a stigma for hearing aids and hearing loss. Some of the personal sound amplifiers on the market come in a variety of form factors, looking more like a Bluetooth headset than a hearing aid. Will we see manufacturers come up with creative form factors that would appeal to a wider audience and break that stigma?
GAZETTE: How big of an obstacle is stigma? Are hearing aids considered an indicator that you are over a certain age?
REED: That’s certainly the stigma, even though hearing aid technology, design and fit have improved and the devices have gotten smaller. Most hearing loss is associated with age, but we see more people in their 50s and 60s. For these young people, there is always this feeling of “Am I going to look old? Or, when still in the workplace, “Are people going to think I’m still competent at my job?” There is also the idea of an association between intelligence and hearing loss, unfortunately. The stigma is absolutely out there, and we encounter it every day.
GAZETTE: Is there potential for disruption in the hearing aid industry as we have seen in others?
REED: I think companies see this as an opportunity to really try to create something new that meets the need. There is continuous innovation and development not only in hearing aids, but also in diagnostic tools. In countries with fewer resources, can we do more remote assessments or lower cost hearing loss assessments so we can provide care at a lower cost? There is a lot of attention there. There was just an article that came out about a new, very low-cost tympanometer – a machine that assesses the movement of the eardrum to look for fluid in the middle ear or holes in the eardrum. It is associated with a smartphone, while a normal tympanometer can cost more than $10,000 and a lot of equipment. This smartphone-based device would greatly facilitate travel and outreach activities in countries that may not have the resources. I think we will see that in the years to come.
GAZETTE: How might the FDA’s decision affect the way you do your job?
REED: As an audiologist, hearing health professional, I’m thrilled. I think the profession is eager to see how this affects our patients and how it affects our care. We know from experience that hearing impaired patients always need professional care and support to maintain the devices, learn how to use the devices, and optimize the devices for their hearing needs. If people are looking for over-the-counter hearing aids and they aren’t meeting their communication needs, it’s important that they know that doesn’t mean more can’t be done for them. This would be when I would recommend seeking a more traditional assessment with a hearing health professional.