Virginia Capitol Connections, Winter 2023 16 FDA’s New OTC Hearing Aid Reality By KRISTIN KOCH For those of us who are hearing healthcare providers, our professions and industry are in the midst of a great deal of change. With the FDA’s final ruling regarding over-the-counter (OTC) hearing aids, new devices and companies have been flooding the market since mid-November. You will likely see OTC hearing aids on drugstore shelves, kiosks at electronics stores and all over the internet. Most of these devices and manufacturers will follow the FDA’s guidance, but there will always be some unscrupulous companies looking to make a buck. The elderly and those with a limited budget will be among the most vulnerable. The FDA has been working on this entirely new category of hearing aids for the past several years. These devices can be sold over the counter, without the guidance of a hearing healthcare professional and without a hearing test. OTC hearing aids are designed for adults with a “perceived” mild to moderate hearing loss. Despite not needing a hearing test, it is still highly recommended. In our clinical experience, most people often underestimate their level of hearing loss. OTC aids are not intended for children, adults with more severe hearing loss, someone who has experienced a sudden hearing loss, or a hearing loss in only one ear. There are also additional red flags for use of OTC aids, including suspicion of ear wax or a foreign object in one or both ears, drainage from an ear, or severe dizziness (vertigo) with hearing loss. These conditions should still be evaluated by a physician, preferably an Ear, Nose and Throat physician, and an Audiologist for a more thorough medical evaluation and hearing test. To be labeled as an “FDA Approved” OTC hearing aid, devices must meet acoustic and electronic standards published in the FDA’s recent ruling. These hearing aids are quite different from the personal-sound-amplification-products (PSAPs) that have been sold in drugstores for a few hundred dollars over the past decades. The OTC hearing aids must meet certain packaging requirements with warning labels and the red flag warnings. These OTC devices will need to be set up by the consumer, likely with the assistance of a smartphone app, or pre-programmed before OTC aids are sent through the mail to a specific person. This may work well for some Virginians, however this may not be the best option for some, especially those without access to smartphone technology, those with vision or dexterity issues or someone who needs additional support. Encourage people to be careful and understand the return policies and warranty details. There is no mandatory return policy, however the FDA has required that if a return policy is offered, it must be clearly stated on the box or label. The average pricing for these OTC hearing aids is still being determined, however most devices currently on the market seem to be ranging from about $600 to over $2,500 for a pair. As a positive, the new OTC hearing aids have increased awareness around hearing loss in general. The goal of any type of hearing aid, either OTCs or traditional hearing aids, is improved communication, better balance with less risk of falling, and maintaining cognitive health. According to the National Institutes of Health, more than 37 million American adults report some trouble hearing and almost 29 million could benefit from using hearing aids. There is now a mountain of evidence that links untreated hearing loss with a higher likelihood of cognitive decline, a greater incidence of falls and more chronic health conditions. OTC hearing aids may be more accessible and more affordable for some Virginians, especially those in rural areas. 888-729-7428 • shavoffice@shav.org • shav.org Continued on next page The Virginia Capitol Connections team thanks Bonnie Atwood for her many years of service as our Editor in Chief Bonnie is a passionate journalist whose career spans five decades. Her work has been featured in numerous publications including, but not limited to, The Journal Messenger, The Richmond Times-Dispatch, Richmond Boomer Magazine, The Student Lawyer, andVirginia Capitol Connections Quarterly Magazine for which she has been Editor-in-Chief for 5 years. She is the chief writer for Tall Poppies Freelance Writing LLC, a woman-owned writing and legislative consulting service. She is a strong advocate for human rights, economic empowerment, education, health, and politics poverty alleviation. Bonnie served as a Public Relations Assistant and support staff for the 2012 Women Who Mean Business Summit. Bonnie is also a proud historian. Bonnie was the initiator of the historical marker honoring the great Chief Black Hawk (Sauk leader), 1767-1838, which stands in Richmond, Virginia, at 12th Street and Main. As the ancient one wrote, To everything there is a season, and a time to every purpose under the heaven. Bonnie submitted her resignation as our Editor. We hope it’s to have more time for writing, and we expect to see her stories in our magazine.V
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