The Ohio Academy of Family Physicians has signed on to a letter to Robert M. Califf, commissioner of the Food and Drug Administration (FDA), asking that the FDA ensure adequate safety measures are in place to protect the millions of Americans who will soon be using over-the-counter (OTC) hearing aids.
The letter thanks FDA for its efforts to provide more affordable and accessible hearing aids by establishing a new category of hearing aids that will soon be available OTC to adult consumers with mild to moderate hearing loss. The FDA’s creation of OTC hearing aids has generated tremendous interest from many stakeholders, particularly among organizations that care greatly about the safety and well-being of consumers and patients.
The letter goes on to state, “Once they are able to do so, consumers will largely purchase these devices without first seeing a medical professional or undergoing any kind of hearing loss assessment. As a result, we believe many consumers will use these devices without knowing whether their medical condition warrants doing so. For these reasons, we call on the FDA to ensure adequate safety measures are in place to protect the millions of Americans who will soon be using OTC hearing aids. We do not believe this is currently the case.”
The letter continues, “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, the American Academy of Audiology, the American Speech-Language-Hearing Association, and the 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.”
“We believe many consumers will be at an increased risk of suffering increased hearing loss simply by using these devices without the inclusion of these recommendations in the final rule. The FDA should not ignore the fact that many consumers who turn to OTC hearing aids for help may also be suffering from other medical conditions that reduce their ability to recognize or react to excessively loud, damaging sounds. This makes these recommendations even more critical. Importantly, the adoption of these recommendations will not compromise efficacy or prevent manufacturers from offering innovative OTC hearing aids. Instead, they will ensure these devices are safe.”
The letter concludes, “Again, we thank the FDA for its continued vigilance in protecting patients and consumers. By including these recommendations in the final rule, we are confident that the FDA will accomplish its goal of increasing access to more affordable hearing aids that are safe and effective for the consumers that use them.”