Very soon, the Food and Drug Administration will take action to help millions of Americans with hearing loss by allowing hearing aids intended for adults with perceived mild to moderate hearing impairment to be sold over the counter. While this is a laudable effort to make hearing aids more affordable and accessible, we are concerned that the FDA’s forthcoming regulation could do more harm than good.
The good news is that physicians and consumers alike are pleased that the FDA is on the verge of allowing the sale of over-the-counter hearing aids. Making hearing aids more accessible can improve physical and mental health, prevent social isolation, and reduce inequities and disparities in hearing care.
However, hearing aids must also be safe, and here is where our concerns lie. The FDA’s proposed rules don’t hue to the law passed by Congress, which limits over-the-counter hearing aids to adults with a “moderate” level of hearing loss or less. The FDA’s proposed rule would appear to allow OTC hearing aids to amplify sounds well beyond these levels.
This is because the FDA has omitted a limit on gain — i.e., the level of amplification that can be applied to sound as it enters the hearing aid. This puts future OTC hearing aid users at risk of experiencing increased hearing loss. Without a limit on gain, these medical devices can amplify sounds far beyond any recognized threshold of moderate hearing loss. We are concerned that this is not what Congress intended when it directed the FDA to create this new category of hearing aids.
Additionally, the FDA is proposing “maximum output” levels — the amplified sound heard by the user — of 120 decibels, exceeding what has been recommended by the American Academy of Otolaryngology — Head and Neck Surgery. This too could lead to increased hearing loss. In fact, as appropriately noted by the Centers for Disease Control and Prevention, sound at this level could possibly cause permanent damage in only nine seconds.
The FDA’s proposed rule does not include an objective tool to help users self-assess their level of hearing loss before purchasing and using an over-the-counter hearing aid. Without such a tool, consumers would have no way to really know if these devices are even appropriate (or safe) for their use. Research shows that consumers have difficulty correctly identifying their level of hearing loss — most people will over- or underestimate their level of hearing loss. This increases the risk that many consumers may ultimately purchase one of these devices, only to find out that it is ineffective, or worse, might damage their hearing because it was not intended for their use.
Early involvement of a hearing care professional would prevent these issues. We recommend strongly that the FDA urge patients to ensure that they play a role in fitting these devices; given that such involvement will typically not happen in the case of over-the-counter hearing aids, the FDA should define a clear standard for what it considers “mild to moderate” hearing loss and provide a reliable method for consumers to self-assess their level of hearing loss before they are able to use these new devices.
Our hope is that these concerns are addressed before hearing aids begin appearing at retail stores. More affordable hearing aids would be great for those with mild to moderate hearing loss and modest financial means, and they will help reduce inequities in hearing health, but “do no harm” should be the FDA’s mantra in this case, so making these devices safe for consumers must be paramount.