FDA Bureaucrats Silently Violate the 2017 Hearing Aid Law: "We Can't Hear You!"
The Food and Drug Administration is violating the law with impunity. COVID-19 is the cover, but not the reason.
Because of state and federal regulation, it is illegal to sell a product called a hearing aid unless your company has been authorized by the FDA. Six firms dominate the industry. There is no open entry into the market by non-certified firms. Second, the sale must be preceded by an examination by a licensed medical professional, called an audiologist. He must have an advanced degree: Au.D.
There is another classification of products, personal sound amplification products (PSAPs). These can be sold over the counter. They sell at a fraction of the cost of a hearing aid. Technically, there is no difference in performance for 80% on people who suffer from hearing loss. But manufacturers and sellers of PSAPs are not allowed to advertise that their products can aid people with hearing loss. "Hearing loss" is defined as a medical condition. The FDA is in charge of setting the rules for treating medical conditions. It excludes PSAPs.
In 2017, a debate finally began in Congress about removing restrictions on the sale of hearing aids. Sellers of PSAPs would be allowed to market PSAPs as solutions to hearing loss. The Federal Trade Commission, which favors the change, held hearings on April 18, 2017. Here, we read:
So in June of last year, following the workshop, the National Academy of Sciences published their study on priorities for improving access and affordability of hearing health care. FDA was a co-sponsor of that study, and we were very pleased with the in-depth review by the very distinguished panel, and all the effort that went into that. They included also some very specific recommendations for FDA. Number one, that we remove the medical evaluation and waiver requirement, because they felt that it really was not adding any appreciable clinical benefit. They thought it could be really handled in the user instructional brochure, outlining things in a written form, rather than requiring the medical evaluation. They also, like the PCAST report, recommended establishment of a new category of OTC hearing devices that could assist adults with mild to moderate hearing loss. They also felt it was very important that we retain some sort of guidance document that would clarify the distinction between hearing aids and PSAPs. So that certainly has been an area that we have focused on in recent months.We did, in December of last year, issue the guidance document on December 10th, which basically indicated that we will not be enforcing the medical evaluation and waiver requirements for individuals 18 years and older. That, of course, was based on the NAS report, on the PCAST recommendations, on the feedback that we got from our public workshop. So based on all of that information and input, we decided that we would not enforce it. We are in the process of considering how we're going to modify the regulations to actually make that formally changed in the regulations. However, for now at least, the labeling regulation is still being enforced (pp. 95-96).
A BILL BECAME LAW
On August 18, 2017 President Trump signed a bill into law: Over-the-Counter Hearing Aid Act. The bill was bipartisan, co-sponsored in the Senate by conservative Republican Charles Grassley of Iowa and liberal Democrat Elizabeth Warren of Massachusetts. In the House, it was co-sponsored by conservative Republican Marsha Blackburn of Tennessee and liberal Joseph Kennedy, Jr. of Massachusetts. The bill passed the Senate by a staggering majority: 94 to one. It had already been approved by the House without a single objection.
The AARP, a lobbying organization for oldsters, wrote this:
The legislation requires the Food and Drug Administration to create a new category for OTC hearing aids, and sets safety and effectiveness standards for the devices. These hearing aids can be sold online, at pharmacies and stores, or by mail order.The legislation is intended to help people with moderate hearing loss who currently must pay an average of $2,400 per ear for prescription devices, according to Nancy Macklin, director of external affairs for the Hearing Loss Association of America. She said that nonprescription hearing aids might cost as little as $500.
The law specified that the FDA must publish standards for marketing of hearing aids that would allow testing for hearing loss and the sale of hearing aids by non-medical salespeople. Medical specialists called audiologists would henceforth no longer have an oligopoly in testing and prescribing hearing aids. There was a deadline: August 18, 2020.
The FDA missed the deadline.
It was clear last year that the FDA was dragging its feet. On December 5, Grassley and Warren issued a joint press release.
Washington – Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Mass.) are today pressing the Food and Drug Administration (FDA) over its lack of action on writing rules to allow the sale of over-the-counter hearing aids.The Over-the-Counter Hearing Aid Act, a bill led by Grassley and Warren, was signed into law in 2017. That law allows the FDA to promulgate regulations categorizing certain hearing aids as “over-the-counter,” and sets an August 2020 deadline for such rules. By allowing hearing aids to be sold over-the-counter, there is more competition in the market and that will result in much lower prices. Last October, the FDA announced that writing those rules would be a priority for the agency, but has shown no sign of progress since.
“…although hearing aids are considered prescription products, they are not generally covered by health insurance or Medicare and can cost thousands of dollars. For seniors or those on limited budgets, at these prices, hearing aids may not be obtainable,” the senators wrote.
In a letter today to the Acting FDA Commissioner, the senators requested a status update on the rules and an expected date for their finalization.
Full text of the letter from Grassley and Warren follows can be found HERE.
Here is the letter:
Dear Dr. Giroir,Hearing loss is one of the most common conditions affecting older Americans. According to the National Institute on Aging, approximately one in three people between the ages of 65 and 74 has hearing loss, and nearly half of older adults over the age of 75 have difficulty hearing. Hearing difficulties can lead to other problems in adults, including depression and a decline in cognitive abilities. Furthermore, studies have shown that older adults with hearing loss have a greater risk of developing dementia. Hearing aids can greatly assist those with hearing loss to lead normal lives. Sadly, although hearing aids are considered prescription products, they are not generally covered by health insurance or Medicare and can cost thousands of dollars. For seniors or those on limited budgets, at these prices, hearing aids may not be obtainable. Of the 48 million Americans who experience age-related hearing loss only around 14 percent are able to afford hearing aids.
In 2017, President Trump signed into law the Over-the-Counter (OTC) Hearing Aid Act, which we introduced with Senators Hassan and Isakson. This law removes outdated regulations blocking consumer access to affordable hearing aids by amending the Food, Drug, and Cosmetic Act, and allowing the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter and issue regulations regarding those hearing aids to ensure this new category of OTC hearing aids meets the same high standards for safety, consumer labeling and manufacturing protections as all medical devices.
In October of 2018, the FDA announced these rules would be a priority on their Fall 2018 Unified Agenda and would be able to deliver the proposed rules well in advance of the August 2020 statutory deadline. It is now December of 2019 and we have yet to see these regulations come to fruition. Given the ever-increasing need for these devices, we request answers to the following questions by no later than December 19, 2019:
1. What is the status of the OTC hearing aid rules and regulations?
2. When do you expect to finalize the OTC hearing aid rules?Thank you in advance for your prompt attention to these matters. Should you have any questions please contact Karen Summar or Kirsten Wing of Finance Committee Staff at 202-224-4515 or Susannah Savage of Senator Warren’s staff at 202-224-4543.
The FDA ignored the letter. It has ignored the law.
THE SILENCE IS DEAFENING
On August 19, 2020, Sara Kobliz's article appeared on FDAblog. She reported:
Earlier this week, FDA was supposed to issue proposed rules—years in the making—implementing over-the-counter (OTC) hearing aid rules, as required by the Food and Drug Administration Reauthorization Act (FDARA) (read HPM’s summary here). Under FDARA, FDA is required to issue proposed rules three years from the Act’s approval on August 18, 2017 and issue final rules 180 days after the close of the proposed regulation comment period. August 18, 2020 has now come and gone with no sign of the proposed rule. In fact, it hasn’t even been added to OMB’s dashboard, suggesting that it hasn’t been sent to OMB for review (though, we note the possibility that the rule could skip OMB review).
She offers one possible reason for the delay: "Given the current state of the world, and FDA’s significant role in addressing COVID-19. . . ." She thinks it has something to do with defining the terminology that preempts state rules.
In my view, the reason is far more bureaucratic in origin. The FDA establishes regulations that are developed by the largest firms in the medical industry. This is the pattern of all regulatory agencies. Economists have a term for this: "regulatory capture." There is a Wikipedia entry on this.
Senators Grassley and Warren sent a memo to the FDA, reminding the agency of the law. The agency did nothing visible to speed up the process.
PSAP manufacturing firms are still prohibited from marketing their products as an aid to people suffering from hearing loss. So, hearing aids are still expensive.
The FDA can defy the law at no risk to its budget.
The more things change, the more they stay the same.