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UVA Audiologists Share Hope, Caution About Newly Announced OTC Hearing Aids

What are the potential impacts of the FDA’s decision to allow a new category of hearing aid for individuals with mild to moderate hearing loss?

Audrey Breen

In a final ruling last week, the U.S Food & Drug Administration announced it would allow hearing aids to be sold over the counter for the first time. Accessibility to hearing aids has long been an issue for a significant number of the 28 million adults experiencing hearing loss.

“You can somewhat compare it to buying reading glasses at your local store versus getting a prescription for eyeglasses from an optometrist based on your eye exam,” said Kristin Roush, an audiologist and coordinator of the Deaf/Hard of Hearing and Accessible Media Services at UVA Student Health. “The glasses you get from your optometrist will specifically address your eyesight needs. Similarly, the prescriptive hearing aids you get from your audiologist will specifically address your hearing needs over time while the over-the-counter ones will make do for certain situations of focused one-on-one listening.”

But according to Roush and her colleague, Cassie Turner, a clinical assistant professor and audiologist at the UVA School of Education and Human Development, there are a number of questions and considerations for consumers to consider.

Q. Can you explain the FDA ruling?

Turner: The discussion of over-the-counter hearing aids has been several years in the making.The final ruling that was just released establishes a new category of hearing aid which is being referred to as the over-the-counter hearing aid. These devices are intended for adults with perceived mild to moderate hearing loss.

We can anticipate that these devices will be available for purchase directly by the consumer from stores and online retailers without a medical examination, comprehensive hearing test, or professional fitting and follow-up services by an audiologist. This ruling is intended to reduce the financial burden of hearing aids and make hearing technology more accessible to consumers.

Q. Why is this decision being described as “historic”?

Roush: Studies have consistently shown that there are many more individuals who could benefit from hearing aids than actually utilize them. There are many barriers that could account for this discrepancy, but cost is certainly one of them. This decision represents an expansion of accessibility to hearing aid technology and the hope is that individuals with mild to moderate hearing loss will now have access to more affordable hearing aid options.

Q. What are some of the differences between OTC and prescription hearing aids?

Turner: Prescription devices are intended for all ages and all degrees of hearing loss. Audiologists carefully fit them and tune them to best meet individual listening goals and provide routine follow-up care to ensure individual satisfaction and proper device function over time.

OTC hearing aids will look like a prescription-based hearing aid and are designed for adults with mild to moderate hearing loss. Individuals will be able to purchase these devices at their local stores and will set them up themselves. There will be differences internally and, at this time, we don’t know what the technical specifications of these products are or how they will vary from one OTC to the next.

Q. What do you see will be gained from this decision? What are your hesitations, if any?

Roush: There are a considerable number of unknowns at this point regarding the capability of OTC hearing aids and how the technology will address an individual’s needs. As these devices become available, we will want to know information about battery life, microchip processing, noise reduction strategies, feedback control, and self-fitting paradigms.

However, I am hopeful that this decision will reduce the barriers of access and affordability, allowing individuals with perceived mild to moderate hearing loss to address their hearing concerns at an earlier stage and reduce the impact of untreated hearing loss.

Q: Speaking of unknowns. What are some questions you will be looking to answer as the OTC hearing aids are made available?

Turner: While I am hopeful, I also am concerned about the lack of evidenced-based practice with OTC hearing aids. I certainly have questions about the technical specifications of the devices and how this might impact the consumer, such as, how accurate the self-fitting paradigms will be and how OTC and prescriptive devices’ benefits compare.

I also have questions about the functional implementation of OTC devices such as how will individuals be instructed on proper device insertion and removal? Will it be clear what to do when the OTC device isn't working or meeting their needs? How will the cost over time compare to prescriptive devices? Will consumers be educated on other available supports such as communication strategies that they can use in their daily lives?

It is important to remember that OTC devices are only intended for individuals with mild to moderate hearing loss and will not meet everyone’s individual listening needs. If you do not find benefit from an OTC device, do not give up. Seek consultation from an audiologist.

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  • Sheila C. Johnson Center for Clinical Services