It’s been nearly five years since President Trump signed into law the Over-the-Counter Hearing Aid Act. The bipartisan bill, introduced by Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.), was intended to make hearing amplification devices much cheaper and more readily accessible. The Act gave the U.S. Food and Drug Administration (FDA) three years to formulate a guidance proposal and an extra six months to collect comments and issue final guidance. Then COVID got in way. Or was it bureaucratic inertia that got in the way. Perhaps it was both.
Last week the two original cosponsors introduced another bill to force the FDA to issue its Final Rule within 30 days of the new law taking effect. The Final Rule would clarify the steps and parameters manufacturers are required to follow for OTC hearing aids to become widespread. The FDA already missed its original 3-year deadline in 2020. To move things along, President Biden issued an Executive Order in July 2021 which ordered the FDA to complete the steps to allow hearing aids to be sold over the counter. The FDA finally proposed a rule in October 2021 but has yet to issue the Final Rule. That’s the second deadline the FDA missed.
Officials are hoping the regulations will encourage cheaper hearing aids, not just authorize the current high-priced ones to be sold directly to consumers without a prescription or a hearing test. Under the updated rules patients with “perceived mild to moderate” hearing loss could purchase air conduction hearing devices in stores or online without consulting an audiologist. Those under 18 and those with severe hearing loss would still require a prescription.
Why has it taken so long? Well remember how Congress passed — and President Obama signed into law — the Sunscreen Innovation Act of 2014? That law was designed to force the FDA to approve more sunscreen ingredients, most of which had been used in Europe for years. After the bill became law eight ingredients used in European sunscreens were submitted to the FDA for approval. The FDA rejected them all. The FDA wanted extensive, detailed industry studies before the agency would add these ingredients to the generally recognized as safe (GRAS) list. The industry refused to perform these expensive studies due to the cost. No amount of Congressional prodding could move the FDA because, well you know, the millions of Europeans who have used these sunscreen products safely for years was not enough proof these ingredients are safe. This was despite the fact skin cancer is the most common form of cancer. The FDA doesn’t feel billions of data points from anecdotal evidence allows it to change the GRAS list; there must be clinical studies. Indeed, in 2019 the FDA proposed tightening sunscreen regulations to reduce the number of sunscreen ingredients even fewer than before the Sunscreen Innovation Act. Congress trying to force the FDA’s hand is like trying to pound a square beg into a round hole, but I digress. Back to OTC hearing aids.
According to a National Health Interview Survey, about 15% of adult Americans (about 38 million people age 18 and over) have some type of hearing loss. Yet, it is thought that only about 20% of those who would benefit from using a hearing aid actually wears one.
Hearing aids can cost anywhere from $2,000 to $8,000 a pair. Many Americans lack insurance coverage for hearing aids and the high cost is a barrier. Some firms like Bose and Apple are already selling types of hearing amplification devices. However, until the final rule is published the field of competitors will remain small. Some of the missing information has to do with the parameters the OTC devices must fall within. This includes amplification, distortion and whether new OTC hearing aids will be required to have substantial equivalence to legacy devices before premarket approval is granted as is the case with many medical devices. This is known as 510(k) premarket notification. Any time a bureaucratic agency is told to do something, it tries and fails to act within its bureaucratic procedures. This should have taken a few FDA employees working a few hours a week less than a year.