Jeanette Contreras portrait

Leaders in Congress support safe OTC hearing aid standards

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By NCL Director of Health Policy Jeanette Contreras

Mild to moderate hearing loss is a difficult reality that millions of Americans struggle with, which is why the availability of over-the-counter (OTC) hearing aids is exciting for those who are impacted by hearing loss. While making OTC hearing aids more accessible is a promising step for consumers, we at NCL would be remiss if we didn’t underscore our concerns around the Food and Drug Administration’s (FDA) proposed OTC hearing regulations as they currently exist.

In December of last year, NCL was one of hundreds of organizations who submitted a comment to FDA’s public docket on the issue; and last month we submitted a letter voicing our concerns to the FDA that was supported by 29 not-for-profit, public health organizations across the country. These organizations collectively represent the concerns of millions of consumers, patients, and individuals impacted by hearing loss.

We want to reiterate our enthusiasm for OTC hearing aids, but as the gold standard of safety in our country, it is imperative that the FDA make sure these devices are safe for consumers and do not worsen a problem they are intended to mitigate. As written, the draft regulations would allow for a maximum sound output level of 120 dBA – equivalent to the volume of a chainsaw or fire engine siren. This is concerning, as exposure to sounds at 120 dB can be dangerous in as little as nine seconds according to the CDC. This is why NCL, along with other leading consumer and healthcare voices, encourage the FDA to follow the recommendations of hearing care professionals, including the American Academy of Otolaryngology–Head and Neck Surgery that recommend a maximum output of 110 dB and a gain limit of 25 dB. Without a limit on gain, OTC hearing aids users will be able to amplify sounds to dangerous levels, and far beyond what Congress authorized when it said these devices must be limited to adults with moderate hearing loss or less.

The safety parameters we are recommending would in no way compromise the efficacy of OTC hearing aids intended for individuals with perceived mild to moderate hearing loss. In fact, a recent study concluded that commercially-available hearing aids programmed according to parameters typical of those used for individuals with mild to moderate hearing loss yield effective output and gain levels and are within the recommended limits specified by leading hearing care organizations and medical experts.

Importantly, the FDA has already cleared several hearing aids for adults with perceived mild to moderate hearing loss that were found to be safe and highly effective during clinical trials. While these devices were authorized under a different category of hearing aids, these devices limit the maximum output to 115 dB or below and gain to 30 dB or less, lower than the amplification limits currently proposed by the FDA. At the very least, the FDA should incorporate these amplification limits in the final OTC hearing aid regulation.

Finally, as we await finalized guidance from the FDA, we applaud leaders in Congress who are standing behind consumers in supporting safe and effective amplification limits. Last month, Congresswoman Betty McCollum (D-MN) and Congresswoman Rosa DeLauro (D-CT) sent a letter to the FDA echoing their safety concerns. The letter states, “[The proposed rule] hurts consumers and patients in two ways. First, it means individuals suffering from greater levels of hearing loss could put off a needed visit with a licensed hearing professional. Doing so could lead to worsening their existing symptoms, delaying an accurate diagnosis and treatment, and even creating irreparable damage to their hearing. Secondly, it means those with perceived mild-to-moderate hearing loss would be exposed to harmful levels of noise that could result in further damage to their long-term hearing. In order to avoid these concerns, FDA should impose a gain limit of 25 dB and an overall output limit of 110 dB.”

Similar to the countless other experts that have also weighed in, we believe that establishing safe amplification limits would not reduce the efficacy of these devices or limit the advancement of innovative technologies. We thank Congresswomen McCollum and DeLauro for being a voice for consumers and patients on this important issue. To learn more about gain and output and how to protect yourself from hearing loss, check out our infographic.

NCL Briefing: measuring the 340B program’s impact on charitable care and operating profits for covered entities

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Join the National Consumers League for a panel discussion with experts from Health Capital Group, the Community Oncology Alliance, and Johns Hopkins on this new white paper, which analyzes 340B’s impact on hospital profit margins and charitable care spending and attempts to quantify the amount of program benefits accruing to covered entities, contract pharmacies and patients.

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NCL leads effort to encourage FDA to adopt safer standards for OTC hearing aids

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March 10, 2022 

Media Contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Katie Brown, katie@nclnet.org, (202) 207-2832 

Washington, DC – Today, National Consumers League (NCL), along with 29 not-for-profit, public health organizations from across the country, sent a letter to the U.S. Food and Drug Administration (FDA) regarding the agency’s ongoing process to establish regulations that will soon allow hearing aids intended for adults with perceived mild to moderate hearing loss to be sold over-the-counter (OTC) without any involvement of a medical professional. As the FDA finishes developing its final OTC hearing aid regulation, we urge the agency to include stronger measures to better protect consumers affected by this new category of medical devices.  

We applaud the FDA for its efforts to provide increased access and affordability through the creation of this new category of hearing aids. At the same time, the FDA must ensure these devices are safe, particularly given that many consumers will purchase OTC hearing aids without knowing their clinical level of hearing loss and not having any support from a medical professional. In addition to hearing loss, many OTC hearing aid users may also have other medical challenges impeding their ability to recognize and/or react to loud or uncomfortable sounds produced by these hearing aids. Under such circumstances, the need to ensure OTC hearing aids fulfill their intended purpose without risking unintended harm cannot be understated. 

The letter states: “To ensure the safety of consumers, we believe the FDA should implement the recommendations of the nation’s leading associations of hearing care professionals, including the American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Audiology, American Speech-Language-Hearing Association, and International Hearing Society. These associations are urging the FDA to lower the maximum sound output to 110 decibels and establish an amplification (or gain) limit of 25 decibels. These associations, as well as respected entities like the World Health Organization and the Centers for Disease Control and Prevention, have made clear that allowing sounds to enter the ears of consumers at the proposed levels can cause serious and permanent hearing damage within mere seconds.” 

Importantly, these recommendations will not have any impact on the FDA’s goal of providing increased access to affordable hearing devices, compromise the effectiveness of OTC hearing aids, or discourage innovation—they will only make them sufficiently safe for consumers with mild to moderate hearing loss.  

Read the full letter HERE. Learn more about the issue here: OTC Hearing Aids- Gain and Output 

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About the National Consumers League (NCL) 

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

 

Talk before you take: The importance of doctor-patient communication before starting a new medication – National Consumers League

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92_kamay.jpgWe’ve all been there. Sitting alone in a cold doctor’s office, listening to a re-run of the Dr. Oz show while waiting for your doctor to come back in the room with a diagnosis and prescription in hand. You can’t wait to leave and get back on the path to wellness. And who could blame you? No one likes to wait—especially when you don’t feel healthy. The doctor comes back, hands you your prescription, and gives you a brief overview about what the medication is and the appropriate dosage. But, what happens next is critical. Do you hop off that cold, uncomfortable patient bed and go on your merry way, or do you ask questions? Specifically, questions pertaining to the risks associated with this prescription medication.

While in recent years, the communication gap between healthcare providers and patients has been met with a fair share of commentary, critique, scholarly review and analysis, we are slowly making progress, thanks in part to numerous campaigns and educational initiatives. Recently, the National Council on Patient Information and Education (NCPIE), a non-profit organization, launched a campaign to help bridge the communication gap with Talk Before You Take.

Launched earlier this year, Talk Before You Take highlights the importance of communicating with your healthcare provider about the benefits and risks of prescribed medications before a prescription is written and filled. The specific aims of the Talk Before You Take are to:

  • Understand medication side effects
  • Avoid adverse drug reactions
  • Improve adherence to medicine regimen(s)
  • Live healthier lives

Here are four tips to help guide your conversation with your healthcare provider about prescription medicines:

  • 1. Talk to your healthcare provider and ask questions about the benefits and potential risks of prescription medicines you take.
  • 2. Tell your healthcare provider about all of the medicines you are taking—including over-the-counter medicines, vitamins, and dietary supplements.
  • 3. Tell your healthcare provider about any allergies or sensitivities that you may have.
  • 4. Read and follow the medicine label and directions.

And remember, even if you get home and realize that you still have questions about your prescription medications; it’s not too late. Don’t hesitate to pick up the phone and call your healthcare provider. Because when it comes to your health, there are no silly questions.