FDA Approves Option To Buy Hearing Aids Without Prescription

This week, the U.S. Food and Drug Administration (FDA) approved a ruling to enable certain hearing aids to be purchased without a prescription. This action will go into effect October 17, 2022, and will likely have a substantial impact on millions of Americans. It is estimated that over 30 million individuals in the United States alone suffer from some degree of hearing impairment. It is the third most common chronic condition in older adults. As many older adults do not undergo routine hearing screening, many of those with a wide range of hearing loss do not receive adequate amplification.

Hearing loss in one or both ears is the most commonly identified congenital condition in newborn babies. Up to 1 in 300 newborns have some degree of hearing loss at birth. Until the late 1990’s, when nearly all states began requiring newborn hearing screening in the first weeks of life, many children with hearing loss were not appropriately evaluated and treated until elementary school or even later into their teen years.

Untreated hearing loss can be associated with communication, speech, and learning issues, social isolation, frustration, and depression. And while there are myriad causes of hearing loss, ranging from genetics to aging, use of hearing aids can be life-changing at any age. But access, costs, and the need for frequent visits to specialists has led to significant roadblocks for millions. Not to mention the stigma of hearing aids being associated with “old age” or a “physical difference” all of these hindrances translates to over 80% of Americans, from babies to adults, who would benefit from hearing aids missing out.

Having hearing aids available to the consumer without the need for a prescription from an audiologist or ear, nose and throat specialist (otolaryngologist) will provide substantial improvement in access, substantial reduction in cost, and very likely substantial reduction in stigma. Dr. Sujana Chandrasekhar, otolaryngologist and Partner at ENT and Allergy Associates, shares her optimism regarding this decision: “Even mild hearing loss, if unremediated, is associated with isolation, depression, and anxiety, and untreated hearing loss is the #1 preventable cause of dementia.” She does caution that people should be aware of the FDA’s published “Red Flags” associated with hearing loss. These are issues which require medical attention, such as ear pain, dizziness, ringing in the ear, bleeding, and sudden changes in hearing.

Dr. Chandrasekhar also notes that the “ease of access and use of digital technology” will allay the stigma of hearing aids being associated with aging. As more people with mild hearing loss start using them, she comments that there may even be a style component, “like when glasses went from being avoided to now people buying fun frames and flaunting them.” Indeed, reading glasses, affectionately known as “readers,” were not too long ago seen as a necessity for the aged, but hardly a sign of style. Now reading glasses brands (which can be purchased without a prescription) are flashing bright colors, thick frames, and celebrities in their ad campaigns. Perhaps hearing aids may be the next fashion statement?

Audiologists have raised concerns that patients not seeking evaluation and intervention by skipping this important component of hearing loss assessment and going directly to purchasing hearing aids on their own would cut into their important work, as well as lead to missed diagnoses of more significant issues related to the ears. Dr. Alison Grimes, Director of Orange County Mobile Hearing Care and former President of the American Academy of Audiology, feels that the new ruling is a good move on the part of the FDA: “Over-the-counter hearing aids...will make people realize they hear better, and they may be more inclined to visit an audiologist.” She feels that people with mild hearing loss may be more inclined to go out and get that hearing aid, especially if finances are an issue and if they don’t want to admit to having a hearing issue in the first place.

One of the major hurdles which this new FDA ruling will overcome is cost. Janice Lintz, CEO of Hearing Access & Innovations and Harvard Kennedy School 2023 MPA Candidate, knows this all-too-well. Her daughter, now a young adult, was diagnosed with hearing loss as a young child. The family soon learned that many insurance companies do not cover the costs of hearing aids, which can come to tens of thousands of dollars. “I couldn’t understand why these devices were so pricey, and they aren’t covered by most health insurance plans or basic Medicare. Hearing aids are unaffordable for so many people in the U.S. and globally,” she recently told The Healthy.com newsletter.

On the issue of whether or not an audiologist or ear specialist needs to be in the loop first, Ms. Lintz agrees with Drs. Chandrasekhar and Grimes: “I think people having greater access to less expensive hearing aids will bring greater awareness to the issue. I think once people start using them, they may seek help if they need it.” Ms. Lintz does raise some concerns with the new ruling, which she notes have not been addressed: “What is disappointing is that the FDA didn’t mandate generic names for features or standard testing for performance. I am unclear how the FDA will know if a device is labeled “false or misleading” if they aren’t testing the hearing aids.”

As with any food or drug that is labeled “FDA-approved,” one should assume that there has been some level of efficacy and safety assessment before it hits the market. This has yet to be the case for individual hearing aids. But if getting those millions of Americans closer to getting their hearing issues addressed means having them try on an off-the-rack hearing aid, perhaps that will lead to not only better hearing, but just as important, to better listening.