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Don’t sacrifice safety when improving access to hearing aids

By Daniel Reidenberg

For the millions of people challenged by some level of hearing loss, the Food and Drug Administration is in the process of finalizing regulations that will allow over-the-counter sales of hearing aids for the first time. The effort to make these devices more accessible is a good thing but, if not done properly and with reasonable safeguards, could ultimately cause over-the-counter hearing-aid users to experience increased hearing loss, particularly consumers suffering other cognitive and physical limitations.

When finalized, the FDA’s proposed regulations will clear the way for over-the-counter hearing aids to be sold to adults with mild to moderate hearing loss. Unfortunately, the FDA’s proposed regulation does not require consumers to undergo any sort of medical evaluation or hearing screening before these devices are purchased. In fact, the law passed by Congress requiring the FDA to create this new category of hearing aids says the devices must be made available without any involvement of a trained medical professional. What this means is that the burden will be on consumers to self-diagnose whether an over-the-counter hearing aid is right for them.

Such a task would be difficult for anyone. Do you know if you have hearing loss? And if so, do you know whether you have “mild to moderate” hearing loss? For the people we work with who are struggling with mental illness in addition to having impaired hearing, this may ultimately be an impossible task. It is important to remember that one out of every five adults in this country faces some sort of mental health challenge. Taking the medical community out of the hearing-aid process raises serious health and safety concerns, particularly given that so many mental illnesses go undiagnosed and untreated.

Equally concerning is that the FDA is proposing to allow manufacturers to build over-the-counter hearing aids with excessively loud amplification limits that could prove dangerous for many consumers. Specifically, the FDA’s proposed regulation would allow over-the-counter hearing aids to amplify sounds up to 120 decibels.

To put that in context, this level of sound would be equivalent to standing next to the siren of a fire truck. Hearing-aid users — again, untrained in diagnosing their level of hearing impairment or at setting proper volume levels — may wear these devices for eight to 10 hours a day. According to the Centers for Disease Control and Prevention, exposure to sound output as high as 120 decibels can cause severe hearing damage in seconds. According to the American Academy of Otolaryngology–Head and Neck Surgery, the FDA’s proposed amplification limits are “too high” and place consumers at risk of suffering “damage similar to that which is caused by those who listen to earbuds at excessive volumes.”

The FDA’s answer to this is that over-the-counter hearing-aid users will have 28 seconds to either remove the device from their ears or lower the volume to avoid serious and potentially permanent harm. For many consumers, especially those with reduced cognitive or physical abilities, this is simply unrealistic.

Again, it’s a positive step to make hearing aids more accessible, but consumer safety should not be sacrificed to do so. The FDA needs to implement stronger safety measures before allowing hearing aids to be sold over-the-counter thereby protecting patients’ physical and emotional health.

Daniel Reidenberg is executive director of Suicide Voices of Awareness, or SAVE (, a suicide-prevention nonprofit in Minneapolis.

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