Over the Counter (OTC) Hearing Aids

As the world of hearing aids continues to evolve and change, audiologists are receiving more questions than ever. Myriad patients have seen news stories or read articles regarding Over the Counter (OTC) hearing aids, and possible Medicare coverage for hearing aids. There are many factors in these complex topics, and many regulations regarding OTC hearing aids are still awaiting final review.

In 2017 a law passed creating a new category of hearing devices, OTC. It wasn’t until two years later in 2019 that the FDA issued guidance on this new category, and as of today we are still awaiting the availability of these devices for patient use. These devices are targeted towards those with perceived mild to moderate hearing loss who are 18 years and older. Children still require a prescription to obtain hearing aids. The main draw of these OTC devices is their affordability compared to traditional hearing aids. However, these devices come with many drawbacks. First, they rely on a patient’s perceived hearing difficulty—which often does not match up with their actual hearing loss. This mismatch could easily result in patients not receiving enough amplification from OTC devices, and thus not receiving the full benefit that hearing aids can provide. A multitude of research has demonstrated that older adults with untreated hearing loss are at up to a five times higher risk of dementia and cognitive decline. If such patients obtain OTC hearing aids, if is very possible they will not be adequate for their hearing loss, and thus patients could still be at a heightened risk.

Additionally, OTC hearing aids have far lower patient satisfaction than traditional hearing aids fit by an audiologist. One study showed that 90% of patients chose the wrong hearing aid based on their hearing loss, when choosing a hearing aid without the assistance of a hearing professional. Only 55% of these patients chose to keep their hearing aid at the end of the study. However, when hearing aids were fit by a professional, 81% of patients wanted to keep their hearing aids—a whopping nearly 30% difference. From the same study, 60% of patients who initially did not want to keep their hearing aids when selected on their own, changed their minds and wanted to keep their hearing aids after having them fit by a professional. As an audiologist I find these numbers to be alarming. My overwhelming concern is that patients will try OTC hearing aids and not find them to be helpful, thus writing off hearing aids altogether. This study demonstrated the importance of having an audiologist properly select and fit hearing aids that will maximize a patient’s benefit and satisfaction.

OTC devices are likely to have a lower level of technology, which would explain their lower price point. Research has shown that patients have the highest satisfaction with the highest level of hearing technology. Thus, OTC devices are very likely to have lower satisfaction levels. This problem again causes concern that patients may not want to pursue hearing aids from a professional after having a bad experience with OTC devices. As an audiologist my primary concern is a patient’s hearing, however my secondary concern is cognitive function—especially for older adults. It is critical for patients to utilize properly fit hearing aids to mitigate the heightened risks of dementia, depression, and social isolation that accompany untreated hearing loss.

As previously stated, the main appeal of OTC devices is their lower price point. Many patients have recently seen articles regarding Medicare hearing aid coverage and see this as a path to more easily affording hearing aids. Unfortunately, as of now no law has been passed stating that Medicare will cover hearing aids. The Bill that would provide hearing aid coverage has only been passed by the House of Representatives, and still needs to be voted on by the Senate. Additionally, even if passed this bill will likely take years to go into effect, just as the OTC law was passed in 2017 but has yet to go into effect. It is also unknown how much coverage would be provided. Within private insurance there is an incredibly wide range of coverage for hearing aids, ranging from $0 coverage up to full coverage without any upper limit. The current Bill also states it would cover 1 hearing aid per hearing loss ear every 5 years—only for individuals with moderately severe, severe, or profound hearing losses. This excludes individuals with moderate levels of hearing loss, which are still significant and require amplification. Currently there is no guidance as to how it will be determined if patients fit into one of these hearing loss categories. Most commonly older adults have better hearing in the low, “boomy” pitches versus the high squeaky pitches—meaning that their hearing loss would not neatly fit into any of these ranges. A patient’s hearing loss is described in terms of multiple ranges, for example a patient may have a “mild to severe hearing loss” meaning their hearing is at a mild level of loss at some frequencies, and a severe level of loss at other frequencies.

Regarding Medicare and hearing aid coverage my advice to patients remains the same—do not postpone obtaining hearing aids to wait for Medicare coverage. Unfortunately as of now there are too many unknowns as to if/when coverage will take place and who will be eligible. Research demonstrates that the sooner a patient begins to use hearing aids, the better. The auditory nerve and organ of hearing benefit from receiving proper stimulation sooner, as this allows the inner ear to continue working and not further decline from lack of use. Overall the theme remains the same—hearing aids properly fit by an audiologist provide the most benefit and patient satisfaction, and the sooner the better.

Rebecca G. Sherman, AuD, F-AAA


https://www.healthyhearing.com/report/53233-Otc-hearing-aids-over-the-counter-devices https://khn.org/news/article/democrats-plan-to-expand-medicare-hearing-benefits-what-can-consumers-expect/ https://www.asha.org/news/2021/house-of-representatives-passes-bill-adding-new-medicare-hearing-benefits/

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