Commercially Available Hearing Aids and the FDA
“Hearing Aids Could Use Some Help”, as one could presume based on the title, is about the massive barriers to adoption of hearing aid technology in the United States. This is not for lack of a market, since a quarter of Americans in their sixties and two thirds of Americans over 70 have hearing loss. This has massive psychological consequences, such as social isolation, increased risk of falls, and increased rates of dementia. However, despite this need for hearing aids, in 2018 only 18.5 percent of medicare beneficiaries over 70 have hearing aids. Hearing aid usage is also lower among women than men and significantly lower in black beneficiaries than white. Additionally, low income seniors using hearing aids declined to 10.8 percent in 2018 from 12.4 percent in 2011. The article immediately attributes this to the prohibitive cost of hearing aids at, on average, $4700 a pair.
As clearly demonstrated, there is a lack of adoption of technology in the network. This is due to a variety of factors. In terms of spread through a social network due to adoption by friends, this is slowed by stigma, a reluctance to get hearing aids due to it being a reminder of aging. Most apparently, the financial burden is what is preventing most people from acquiring hearing aids. Most medical insurance does not cover hearing loss and hearing aids, meaning that on average people pay 79% of the cost out of pocket. Legislature requiring Medicare and other insurances to cover hearing aids has yet to be passed. An additional barrier to entry and adoption of hearing aids is that, as it currently stands, those needing hearing aids must visit an audiologist multiple times for testing, fitting, and adjustment, which again adds to costs. There are also only 18,000 audiologists in the United States, making them inaccessible to those living in rural and remote areas.
Since the act of even getting the hearing aids, not to mention the cost, is so inaccessible for many in need, in 2017 legislation was passed allowing hearing aids to be sold directly to consumers without prescription. However, for this to go into effect, the FDA needs to establish a set of regulations such that products can apply to be FDA certified. However, due to the pandemic, these regulations which should have been completed in August of 2020 have been significantly delayed due to the FDA focusing its efforts on emergency use authorizations for PPE, vaccines, and many other coronavirus related concerns. An additional impediment to the speed of the DGA is that no other country has over-the-counter hearing aids, meaning there are no requirements or precedents, so it all must be done from scratch. Once the FDA has established regulations, hearing aids at much lower prices will be available at any pharmacy, supermarket, or other big shopping location.
As it currently stands, without these FDA regulations, companies are allowed to produce and sell Personal Sound Amplification Devices (PSADs), so long as they don’t advertise themselves as hearing aids. However, due to there being no oversight on these products, quality varies enormously. Products are being sold for $50 advertising miracle cures to hearing loss and are effectively bogus, thus leading to a lack of trust in these products. There is therefore a market for lemons, where consumers have no idea whether or not any of these PSADs are effective. By passing these FDA regulations, this market with unequal information will effectively be eliminated. Effective products will bear the FDA seal, showing those not-approved to be useless products that consumers will not purchase. However, without these regulations, the producers will always know more than the consumers. Finally, once these regulations are passed, companies that have been waiting for years for this will release an onslaught of over-the-counter products, technologies, and advertisements. Initially this will mean that there will be an excess of information that is difficult for the average person to parse, further clouding this market with unequal information.
In summary, hearing aids are currently far under adopted as a technology due to several barriers of entry: social stigma, a lack of medical professionals in rural area, and prohibitive costs. The FDA is currently working to make a set of standards so that hearing aids do not need to be acquired from a medical professional. As the market for commercially available hearing devices currently stands, there is unequal information as consumers do not trust the products due to vastly varying product quality, again due to the lack of FDA approved regulations on commercial hearing devices. Once FDA passes regulations, hopefully in 2021, government-certified hearing aids should be available at much lower cost and at higher convenience to all those who need it, thus eliminating the barriers to adoption and market with the unequal information.