Even the Academy of Doctors of Audiology, which previously did not support over-the-counter hearing aids, got behind the bill. Audiologists long had an interest in resisting cheap hearing aids because if you needed to adjust your prescription hearing aid, you had to go to an audiologist; with over-the-counter hearing aids, you just fiddle with an app on your smartphone. But the ADA saw the writing on the wall and got on board. Another reason the ADA came out for the bill was that audiologists, who supply patients with prescription hearing aids, got fed up with paying exorbitant prices for them. According to Matt Stoller, research director at the American Economic Liberties Project, independent audiologists pay three to five times as much as Costco does for the same hearing aid. (I should clarify that the audiologists I’m talking about here are independent audiologists; audiologists directly affiliated with or employed by the prescription hearing aid firms opposed the bill.)
The Big Five’s strategy now is to impose regulatory limits on over-the-counter hearing aids that will limit who can use them. The FDA’s proposed rule would preempt over-the-counter hearing aids from state and local laws that would limit their use; the Big Five wants to keep those state and local impediments. The rule allows over-the-counter hearing aids to be as loud as 120 decibels and does not regulate how much they may amplify sound. A Warren aide told me that the Cochlear Center for Hearing and Public Health at Johns Hopkins signed off on these parameters, but the Big Five say 120 decibels is too loud (they want 110 dB) and that amplification should be limited. Again, the purpose is to limit the market for over-the-counter hearing aids—in this instance, by restricting their use to people who require their hearing aids to be louder. The 2017 law says the over-the-counter hearing aids should be marketed to those with “mild to moderate hearing impairment”; the Big Five fought bitterly to strike the words “to moderate,” but lost.
The Big Five say they’re only trying to make the new products as safe as possible, but Warren and Grassley say they’re trying to restrict the population that can use them. “The only way you’re going to die from using a hearing aid is if you eat it,” Stephanie Czuhajewski, the ADA’s executive director, told me.