Most of us likely have heard the Verizon Wireless character say, “can you hear me now?” Those commercials ran from 2002 to 2011 because the message was simple — low-cost minutes are not valuable if the signal quality is not audible. Clearly, Verizon thought this was a winning campaign that helped it grow its market share.
Aduhelm, unfortunately, received accelerated approval from the FDA in June 2021, and Leqembi, which some experts view as being marginally effective, received traditional approval from the FDA in July 2023. Manufacturers are clamoring for attention as they race to develop drugs to treat Alzheimer’s disease. A review of the pipeline shows that of the 36 drugs in Phase 3 trials, seven (19%) are anti-amyloid and 11 (31%) target transmitter receptor mechanisms; the remaining 18 drugs span seven other mechanisms of action. And only 12 of the 36 drugs in Phase 3 trials are approved for other indications. Payers are surely watching these developments and preparing to manage the associated utilization and costs.
A growing body of evidence has shown that what’s good for the heart is good for the brain. And now we have stronger evidence than ever that what’s good for the ears is good for the brain. But are payers listening to the latest evidence on hearing aids? If so, their silence is deafening.
The latest evidence
Studies have shown that people with hearing loss are at increased risk of dementia. Potential explanations include the reallocation and/or deterioration of cognitive resources, social isolation, loneliness, and depression.
One such study published in May 2023 found a 42% higher risk of dementia in people with hearing loss, compared with those without hearing impairment. More importantly, this study measured how the use of hearing aids can reduce this risk. Compared with participants without hearing loss, people with hearing loss and who did not use hearing aids had an increased risk of all-cause dementia, whereas no increased risk was found in people with hearing loss who used hearing aids. The attributable risk (AR) proportion (calculated from the hazard ratio) of hearing loss without hearing aids was 29.08% after controlling for 14 variables (age, sex, ethnicity, education, income, Townsend index of deprivation, smoking status, alcohol intake, physical activity, body mass index, hypertension status, diabetes status, cardiovascular disease status and APOE e4 allele status). In other words, for those with hearing loss and not using hearing aids, 29.08% of the all-cause dementia could have been prevented if hearing aids were used. The findings were similar for subtypes of dementia — for example, the AR proportion of hearing loss without hearing aids for people with Alzheimer’s diseases was 23.66%. Interestingly, the association between hearing aid use and dementia was mediated by reducing social isolation and loneliness, and by improving depressed mood.
Issues with and objections to this study are loud and clear. Even though the sample was large (more than 400,000), the UK Biobank is a self-selecting sample of the UK population and, as such, may not be generalizable to the entire UK population, let alone the US population. And there are limitations due to both hearing and hearing aid use being self-reported. But the biggest weakness of this evidence is that it is based on an observational study — and any observed correlation is not proof of causation. Instead of the inference that hearing aids can protect against dementia, it could be that those developing dementia have trouble adopting or using hearing aids. Only a randomized controlled trial (RCT) can control for between-group differences and yield proof of causation.
The National Institutes of Health was certainly listening to the accumulation of evidence when it funded a randomized study that was published in July 2023. That study compared the rate of cognitive decline over a 3-year period between people who received hearing aids and instruction in how to use them and people who did not receive hearing aids, but, instead, received an education program focused on healthy aging. A difference in the rate of cognitive decline was not detected between the two groups. However, the benefit of the hearing aids was significant for those at greater risk. The subset of participants who were previously enrolled in a separate heart-health study were older, had more risk factors for cognitive decline, and had lower baseline cognitive scores than the healthy de novo participants. The heart-health study participants receiving hearing aids had an almost 50% reduction in the rate of cognitive decline versus the de novo participants.
So, there’s good evidence that hearing aids reduce cognitive decline in older adults at increased risk for it. As we learn more, we’ll be better able to identify those at increased risk and those most likely to benefit from hearing interventions. And that evidence should help to inform payers’ coverage policies.
Current coverage
While Medicare Parts A and B do not cover hearing aids, nearly all Medicare Advantage plans voluntarily cover hearing aids as an extra benefit to help attract and retain enrollees. But this coverage varies. Among Medicare Advantage enrollees, a Kaiser Family Foundation analysis shows that:
- 59% have no maximum dollar limit but have a frequency limit
- 32% have a maximum dollar and have a frequency limit
- 8% have a maximum dollar limit but have no frequency limit
- 1% have no maximum dollar limit and have no frequency limit
Congress passed an act in 2017 requiring the FDA to create a category of over-the-counter hearing aids. Five years later, the FDA issued a rule allowing for over-the-counter sales of hearing aids — making them more accessible and affordable to consumers with perceived mild to moderate hearing impairment. Hearing aids intended for severe hearing impairment remain prescription devices.
Future coverage
The Medicare Hearing Aid Coverage Act of 2023 (HR 244) was introduced in January 2023. What if Congress listens to the growing evidence on hearing aids? And rather than viewing hearing aids as being inflationary, what if hearing aids for high-risk Medicare beneficiaries were viewed as a source of potential cost savings?
For a moment, let’s suppose targeted hearing aid coverage does not lower costs. Might it be a bigger bang for the buck than drugs used to treat Alzheimer’s disease? Drug manufacturers are unlikely to fund a head-to-head trial, and some hearing aid manufacturers may not have deep enough pockets to do so. (Yoo-hoo… NIH?) A 2022 study published in iScience showed that Apple’s AirPods Pro helps people with mild to moderate hearing loss when used with a smartphone. In theory, Apple could enter and disrupt the OTC hearing aid market. And with a market cap of $2.8 trillion, Apple could easily fund a RCT to prove the impact of its tech and, if so inclined, even take on drug manufacturers directly with a head-to-head trial. By the way, a pair of AirPods Pro costs $200 (and an iPhone 14 Pro costs about $1,000) whereas the cost of Leqembi is about $2,000 per month. An ICER comparative effectiveness review of both OTC and prescription hearing aids might resonate with payers. For the right patients, use of hearing aids with a drug may prove to be most cost effective.
Cognitive decline aside, what about the potential medical and pharmacy cost offsets by reducing depression?
Coverage of hearing aids for Medicare beneficiaries, especially for those at higher risk for cognitive decline, rings true. Can you hear me now?
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