October 25, 2021
Published by Brandon Sawalich
Hearing loss impacts every facet of a person’s life — their ability to connect with family, friends and their community. Untreated hearing loss can have serious, lasting effects on physical and mental well-being. Adults with hearing loss are up to five times more likely to develop dementia. They also have an increased risk for social isolation, loneliness and falls. Despite this research, on average, people wait roughly 7 years between first noticing their hearing loss and finally addressing it. It’s time for that to change. Here are three things that must happen first.
Know the Facts
Approximately one-third of the roughly 48 million Americans with hearing loss actually use hearing aids, but research supports that reducing the cost does not automatically equal increased utilization. Stigma remains a factor. We’ve seen this in Japan, the United Kingdom and, most recently, in Iceland where national health insurance fully subsidizes the cost of new hearing aids every four years. Yet, despite this financial assistance, less than a quarter of Icelanders with hearing loss use hearing aids. Asserting that cost is the driving factor of whether an individual seeks help is a good talking point, but it isn’t looking at the whole picture. And if you don’t look at all aspects of an issue, how are you going to solve it?
Last week, the FDA released its proposed regulations around over-the-counter (OTC) hearing aids. OTC devices are meant to help people with perceived mild-to-moderate hearing loss. We welcomed this announcement, and it could not have come soon enough. Over the past four years between when Congress passed the Over-the-Counter Hearing Aid Act and the FDA’s recent announcement, some companies have used this waiting period to market their plug-and-play amplifiers differently. Misinformation by companies putting profit over patient satisfaction has forced 17 states’ attorneys general to issue consumer warnings about these oftentimes ineffective and potentially harmful devices. Michigan’s attorney general recently ordered a company to stop selling devices advertised as hearing aids that were really just personal sound amplification products. A hearing aid is a medical device that is regulated by the FDA. It is not a consumer electronic device that you can buy online, stick in your ears and start hearing clearly again.
To make meaningful change, to get people the help they need, we must work together to find solutions that put patients and their overall health first. In addition to not involving the hearing professional, there are some initial concerns about the FDA’s proposal around patient safety and satisfaction.
In a consensus paper authored by hearing professional organizations and supported by the Hearing Industries Association and Starkey, there was an important recommendation that limits output to 110 decibels (dB). The FDA proposal states up to 120 dB, which is the equivalent output of a chainsaw. This may not seem like a big difference, but if the device’s output is too high, it can actually damage the user’s hearing even more. These output limits could also effectively eviscerate the intent of the statute by stretching the OTC category from perceived mild-to-moderate hearing loss and into severe hearing loss. Additionally, the FDA proposed regulations did not put any limit on max gain, whereas the consensus paper recommended a max gain of 25 dB. Without a limitation on gain, it moves beyond the intended application for those with mild-to-moderate degrees of hearing loss, potentially leading to negative consequences for hearing aid users including loudness discomfort and reduced sound quality.
Again, while details like these may seem small, they only stress the importance of having the hearing professional be part of the conversations happening in Washington around topics like OTC. There is a way to roll out these devices, but we must do it correctly.
One of the most overarching recommendations from this group of audiologists, academics, consumer groups and hearing industry leaders was that the hearing professional should be involved in the process. Each hearing loss is unique. Like a thumb print, no two ears are alike. This means hearing loss is most effectively treated with individualized care through a trained and licensed hearing healthcare professional. From the initial hearing test to identify the cause of an individual’s hearing loss to determining the best course of personalized treatment, the hearing professional is essential to leading the patient through this process, especially as a patient’s hearing loss changes throughout their life.
Do What You Believe is Right
Successfully achieving the best outcomes for patients requires clarifying misinformation and amplifying the voices of those affected. As the largest American-owned hearing aid manufacturer, Starkey is leading this effort. We launched a new initiative called Listen Carefully to educate policymakers about these issues and, just as importantly, to give those impacted most a voice in Washington. Now that the FDA has opened up a public comment period on OTC hearing aids, it is absolutely necessary that those with hearing loss, their families and the hearing professional be part of these conversations, and Starkey will help make sure they are heard. We look forward to working with the FDA as we submit comments and ensure we can all come together to support a regulation that extends access to hearing aids, while protecting patient safety and satisfaction. It is also imperative for the public to understand that hearing healthcare professionals are an essential resource, as they determine not only which products are right for each patient’s unique hearing loss but also to prevent more damage to their hearing.
We all know someone who suffers from hearing loss, and this effort is going to take all of us to compel policymakers to make real, sustainable and common-sense changes. Increasing access to hearing healthcare resources means opening entire worlds for Americans with hearing loss. Those individuals deserve solutions on this issue, and we can provide them by clarifying the facts, working together and doing what’s right.