The President’s Council of Advisors on Science and Technology group (PCAST), under President Obama, was directed to provide policy recommendations for the benefit science, technology, and innovation to form policy that benefits the American people. One policy suggestion formed was due in part to the research done by Frank Lin, MD, of Johns Hopkins University. His groundbreaking research demonstrates that untreated hearing loss was associated with earlier onset of cognitive decline (of an average of three years) for those over the age of 65. Statistics show that only 25% of those with hearing loss obtain treatment. When surveying those with untreated hearing loss, the most cited reason for delaying hearing loss treatment was the price of hearing aids, as well as lack of insurance coverage. The above-mentioned statistics helped form policy recommendations aimed at making hearing aids more accessible by providing over-the-counter (OTC) options, and in 2017 the FDA Reauthorization Act was passed with bi-partisan support in both the House and Senate and was signed into law by President Trump.
The FDA Reauthorization Act was comprised of many components and included legislation designed to provide greater access and increased affordability for treating mild to moderate hearing loss by allowing hearing aid manufacturers to sell hearing aids over the counter in addition to selling them through typical hearing aid and audiology clinics. The health ramifications for people obtaining hearing aids over the counter without proper testing and verification of settings was (and still is) concerning and thorough, detailed guidelines needed to be developed before this law could take effect. The FDA, after taking years to tackle this daunting challenge, released their proposed guidelines, and the comment period has now closed.
We expect to see over-the-counter solutions available to the public in the fall, and we are excited for the opportunity to work with these new solutions to hearing loss. These OTC devices will not be prescriptively fit solutions, meaning they cannot be programmed by an audiologist on a computer. However, as audiologists, we can help orient the patient to the device and confirm that the OTC devices are fully correcting the patient’s impairment. For those with milder forms of loss, OTC hearing aids may provide a less expensive step into hearing loss treatment.
At Adaptive Audiology Solutions, we are constantly striving to find ways to improve our patient’s care and experience. If you are interested in learning more about over-the-counter (OTC) hearing aids or Adaptive Audiology Solutions, give us a call at 712-775-2625 for a free 30 minute consultation or to learn about upcoming open house events.