Policy Three Cheers For Over-The-Counter Hearing Aids Brian Blase Contributor The Apothecary Contributor Group Opinions expressed by Forbes Contributors are their own. Aug 21, 2022, 03:57pm EDT | Share to Facebook Share to Twitter Share to Linkedin I coauthored this piece with Drew Keyes, the senior policy analyst at Paragon Health Institute. This past week, the Food and Drug Administration finally took the commonsense step to allow patients to buy hearing aids over the counter (OTC), or without a prescription.
This action should help millions of Americans with hearing loss by reducing the cost, including wait times, of getting the assistance that they need. It should also spur competition among hearing aid manufacturers and distributors to better meet patient needs, patients like Brian Barbera. Brian Barbera’s Struggle to Get Needed Hearing Assistance When Brian Barbera sought new hearing aids earlier this year, he knew it was going to be a difficult undertaking.
Brian is 33 and has experienced bilateral mild-to-moderate hearing loss since the first grade. Ever since, he’s worn custom hearing aids. His current ones are now eight years old, well past time to be replaced.
His right hearing aid stopped working so he took it to his audiologist. That visit, not covered by insurance, cost $250. The hearing aids were out of date, he was told.
So, they contacted the manufacturer. After initially being told they were too old to repair, the manufacturer eventually agreed to repair them for another $350. However, Brian was also told that the old hearing aids were liable to break again.
His audiologist recommended he get re-tested for a new pair. When he settled on a new pair of hearing aids, he finally had to confront the price: nearly $7,000 for the pair, and his insurance didn’t cover it. Many patients would have given up there as most people with hearing loss do not use hearing aids, but Brian kept haggling.
His insurance company encouraged him to use a third-party vendor, which got the price down to roughly $4,000. MORE FOR YOU Biden’s Proposed IRS Bank Account Snooping Authority Runs Into State Resistance 2021 Diversity Green Card Lottery Winners To Be Shut Out Because Of Visa Deadline The Swamp Grew – Even Under President Donald Trump He ordered them and when they finally arrived, they caused him to have headaches and other side effects. Brian returned them.
He ended up getting the old ones repaired, at a total financial cost of $600 (including the audiologist appointment) plus a variety of inconveniences along the way. Brian’s situation is faced by many others. This over-complicated, cost-prohibitive system is broken.
Hearing-impaired individuals know what they need and shouldn’t face a system that requires repeated visits to a specialist with limited options for aids. By establishing a new regulatory framework to allow hearing aids to be sold OTC, patients like Brian will have more options to access the care they need with greater convenience and lower costs. Biden’s Executive Order Spurred FDA Action In 2017, Congress passed , and President Trump signed, the FDA Reauthorization Act of 2017, which included the Over-the-Counter Hearing Aid Act.
This legislation directed the FDA to create an OTC hearing aid category for people with low to moderate hearing loss. The federal government, however, hardly ever acts quickly. Slow action results from both large bureaucracies’ lengthy review processes and aversion to change and from special interests that benefit from the status quo—in this case audiologists and certain manufacturers—and that lobby to protect their regulatory advantage.
President Biden deserves some credit for FDA’s action. Since FDA failed to take timely actions consistent with the 2017 law, he issued an executive order in July 2021, directing action from FDA. According to the order, “[a] major driver of the expense is that consumers must get them from a doctor or a specialist, even though experts agree that medical evaluation is not necessary.
Rather, this requirement serves only as red tape and a barrier to more companies selling hearing aids. ” The order highlighted that the average hearing aid price is about $5,000 per pair. Individual hearing aids, which vary based on the patient’s needs, start at $1,500 per aid and can be as much as nearly $5,000 per aid .
As Brian experienced, those costs are typically paid out of pocket. Benefits of OTC Hearing Aids for Patients The FDA’s deregulatory action reduces the cost of people obtaining hearing aids and opens the door for innovators to better meet the needs of millions of patients. In comments on the proposed rule, many hearing-impaired people wrote that this deregulation would permit them to access the devices they’ve needed for years.
While Brian was fortunate to always have access to hearing aids, even if they were diminished in quality, far too many Americans facing hearing loss simply cannot afford both the specialist visits, which can also involve taking time off work, and then the device. These burdens are especially acute for people in rural areas who may not have access to a local audiologist. The reality is that people generally know if they are hearing-impaired.
Some people with hearing loss turn to personal sound amplification products (PSAPs), although these are legally forbidden from being marketed toward people with hearing loss. The FDA’s actions should permit PSAP manufacturers a way to produce and market products better tailored to the needs of the hearing-impaired. When this rule takes effect, patients will be able to simply walk into a Best Buy BBY or Walmart WMT or log on to Amazon AMZN instead of making unnecessary appointments with a specialist and jumping through hoops with their insurance company.
These companies specialize in positive consumer experiences and will ensure that it is as easy as possible for consumers to understand the differences between the devices and choose the ones that work best for them. By reducing the regulatory hurdles hearing aid manufacturers face to get their products to patients, the rule will make way for a more competitive market. With more companies competing in the space, and the products readily available to the general public, the variety of products will increase and prices will decline.
For example, PSAP manufacturers will likely have a pathway to helping patients with hearing loss, a pathway which is currently frozen by government regulations. The Biden administration thinks OTC hearing aids could save patients up to $2,800. While those price savings are likely optimistic, many hearing-impaired patients will have improved quality of life from this action.
While right now Brian needs custom-fit hearing aids, he thinks having OTC options will give him a real choice next time his hearing aids fail or when he looks for an upgrade. He won’t be beholden to a rigid bureaucracy, and, he believes, the OTC options could spark innovation that leads to new hearing aids that better meet his future needs. As Brian told us, “This has real impacts on day-to-day life.
I really look forward to having more options and hopefully more affordable ones. ” Building on this Action The Biden administration should continue efforts that increase patient access to care and treatment. One area to tackle: the enormous FDA regulatory burdens that cause incredibly high costs to bring new drugs to market.
In June, the FDA proposed a separate rule that would allow for increased access to OTC pharmaceutical drugs. Similar reforms could be made to help people who need eyeglasses and contact lenses. Such reforms, built around expanding choice and competition and getting government out of the way, will benefit patients, unlike the harmful impact that will result from the policies in the Inflation Reduction Act that expand government power and put in place price controls.
Patients should be in control over their health care. They know when hearing loss is becoming an issue, and the government’s barriers to accessing what they need should be removed. The FDA’s action, following congressional legislation, to permit OTC hearing aids is a commonsense, patient-centered reform that the Biden administration and the Congress should look to build upon.
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