Across the country right now, big-box stores and corner pharmacies should be preparing to stock the first low-price hearing aids for sale directly to customers.

Companies that make electronics — companies with names like Apple and Samsung — should be getting into the hearing aid business, too, lending their significant design and technological capabilities to a field that could use it.

But these initiatives, positive developments for the millions of Americans who are hard of hearing, are on hold. The Food and Drug Administration, which will be turned over to the Biden administration Jan. 20, should get them moving again.

Hearing aids are available now only through a prescription with an audiologist, the result of a 1977 regulation that says only state-licensed providers can prescribe and sell hearing aids. Often, testing, fitting and sales is packaged into one expensive package — the average cost of hearing aids is $4,700 per pair.

For a lot of Americans, that money comes all out of pocket. Maine law requires health insurance carriers to cover hearing aids — a minimum $3,000 per hearing aid every 36 months — but most seniors are on Medicare, which covers testing but not the hardware.

A quarter of Americans in their 60s and nearly two-thirds over 70 have hearing loss. But in 2018, only 18.5% of Medicare beneficiaries over 70 had a hearing aid; for low-income recipients, the percentage is even lower. The high cost is one of the reasons most cited for the shortfall.

A 2017 law passed by Congress allows direct sales over the counter to consumers, without a prescription needed. The law is expected to result in the price of effective hearing aids falling to one-quarter, maybe less, of their current cost.

The next step was for the FDA to draft regulations on the safety and effectiveness for over-the-counter hearing aids, with a deadline of August 2020. After a public comment period, the agency then works on a final rule, which is supposed to take effect in May 2021.

But, as The New York Times recently reported, the draft rules are nowhere to be found. The FDA’s focus on COVID-19 is part of the hold-up, for sure, but as a recent op-ed in the New England Journal of Medicine pointed out, the agency has managed to release rules related to other issues in recent months.

President Biden’s FDA should move get this done sooner rather than later. The law would not only lower prices and improve variety by giving hearing aid suppliers some much-needed competition — the speaker company Bose, for instance, is working on a OTC hearing aid, and other such companies are sure to be right behind — but it would also make it easier for people to get hearing aids in places where audiologists are scarce, the case in much of rural America.

Right now, the only option for Americans who can’t afford a hearing aid is to pick up one of those cheap “personal sound amplification” products that are found everywhere. Though they by law can’t be advertised as a remedy for hearing loss, and most don’t do much at all, they remain popular for lack of a better choice.

Americans with hearing loss shouldn’t have to settle for remedies that are either too expensive or ineffective. It’s time to finish what the 2017 law started.

 


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