By NCL Director of Health Policy Jeanette Contreras
Whether it be listening to your grandchildren share a story or having dinner with a friend, many consumers rely on devices to help them hear and understand speech every day. Hearing loss is something that we need to be mindful of at all ages, and as consumers, we look to our nation’s regulators to make sure these devices are safe to use.
Some people with hearing loss are able to work closely with hearing care professionals to finely adjust their hearing aids at sound levels that enable them to hear speech at comfortable levels without causing any harm. But, as more Americans struggle with their hearing, accessible hearing aids becomes increasingly important. Proposed regulations by the Food and Drug Administration will allow hearing aids to be sold over-the-counter to adults with mild-to-moderate hearing loss, a step forward in making them more affordable and accessible.
While these regulations are positive for access, the FDA’s proposed thresholds for volume or output for over-the-counter hearing devices are more in line with those for earbuds people use to listen to music for short periods than they are for hearing aids that are worn for several hours a day. These draft rules would allow a maximum sound output level of between 115 and 120 dBA, which is the equivalent to the volume of a chain saw. According to the CDC, exposure of sounds at 120 dB could become dangerous in as little as nine seconds. As you can imagine, being exposed to this level of sound for long periods of time is unsafe and could increase hearing loss and significantly damage the ear.
Hence, there is widespread concern among hearing care professionals that allowing an unnecessarily high level of amplification can lead to further hearing loss. Leading hearing care associations recommend a maximum output limit of 110 dBA for OTC hearing aids and establishing a gain limit of 25 dB.
As the leading consumer healthcare organization, we applaud the FDA’s efforts to increase access to hearing aids for those who need them. We do hope that the FDA will adjust its proposal, so it is in line with the recommendations of hearing care professionals before finalizing the regulations. Consumers shouldn’t be concerned that they may find their situation worsened by devices that are intended to help.
To learn more about gain and output and how to protect yourself from hearing loss, check out our new infographic.