OTC Gets My OK!

Gael Hannan
August 7, 2017

The topic of Over-the-Counter (OTC) hearing aids is of intense personal and professional interest to me.  However, I’m Canadian and our hearing loss advocacy on OTC is years behind that of our American colleagues. But I don’t feel qualified to write about the issue from the consumer point of view because, quite frankly, like many Canadians, the American health system completely baffles me.  So, I’ve asked my friend, renowned writer and advocate, Katherine Bouton, to give a consumer perspective on OTC devices.  She does so in the following article modified for the Better Hearing Consumer.  – Gael Hannan


By Katherine Bouton


Last week (August 3), the U.S. Senate passed the Over-the-Counter Hearing Aid Act of 2017, which had earlier passed the House of Representatives. Once it is signed by the President, it will become law.

Why does the United States need an over-the-counter hearing aid act? What’s wrong with conventional hearing aids sold through audiologists and hearing aid dispensers? The answer is that nothing is wrong with them, but not everyone needs these expensive devices and services. The average cost of a hearing aid is $2400, which is not generally covered by insurance. Medicare, which covers most Americans over 65 (the age with the largest degree of hearing loss), does not cover hearing aids at all.

What exactly is an over the counter hearing aid?

We already have a device available over the counter that corrects hearing loss. So what is that if not an OTC hearing aid?  It’s a PSAP, a Personal Sound Amplification Product, which can cost anywhere from $50 to $500.  A PSAP can be marketed as a sound amplifier but only for people with normal hearing.

An OTC hearing aid will probably do what a good PSAP already does, but with FDA approval. It will be a digital device, possibly with directional microphones, Bluetooth capability and a telecoil, and presumably will cost $1000 or less. An OTC hearing aid will be sold direct to the consumer. The choice to work with an audiologist or hearing aid dispenser is the consumer’s.

An OTC hearing aid will be subject to FDA safety and efficacy standards, which PSAP’s currently are not. OTC hearing aids are not for people with severe hearing loss, single sided hearing loss, or hearing loss caused by a number of medical conditions.

Why do I, who can never benefit from an OTC aid, support it? A free market in hearing aids is good for everyone with hearing loss.

Four out of five older Americans with hearing loss ignore it, so clearly something needs to change. Many cannot afford hearing aids or worry about stigma. More widespread hearing devices of all kinds would help with both those issues. Many believe that OTC hearing aids will be a gateway device for the 85 percent of people with hearing loss who do not now treat their loss.

Some people worry that health insurance will not cover an over-the-counter product. But in my opinion, Medicare and other coverage will never happen unless hearing aid prices down come down. It’s possible that Medicare may not cover OTC hearing aids, but it might recognize more serious hearing loss as the legitimate medical condition that it is. So those of us who have to pay $3000-$4000 for hearing aids may at last get some relief from Medicare. Those with mild to moderate loss can benefit from much less expensive hearing aids.

Right now, an OTC hearing aid remains a concept, not a product. Once the bill is signed into law, it will go to the FDA, which will begin drafting rules and regulations for it, including labeling indicating who these hearing aids are intended for, and who should seek medical advice. This could take up to three years.

Meanwhile, the Hearing Loss Association of America, which strongly backed the bill, urged consumers not to wait If they think they have a hearing loss. HLAA recommends seeing an audiologist or hearing instrument specialist if you are having trouble on the phone, asking others to repeat, turning up the volume on your television, or showing other warning signs. “Untreated hearing loss can cause falls, isolation, depression, anxiety, and it has been shown that there is a link to cognition,” their statement said. “Hearing loss should be prevented, screened for, and treated without delay.”

Many in the field of hearing loss see this bill as an unmitigated positive development. Competition will bring prices down. Ubiquitous use will end stigma. What’s not to like?


Katherine Bouton is the author of “Shouting Won’t Help: Why I – and 50 Million Other Americans – Can’t Hear You.” She is on the Board of Trustees of the Hearing Loss Association of America. Portions of this post appeared in slightly different form on “Hearing Aids, Hearing Loss, Hearing Help,” at katherinebouton.com


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  1. We have to be careful not to give anyone the idea that a personal hearing device, whether it be an OTC hearing aid, a PSAP or a costly hearing instrument that is fitted and sold by a hearing healthcare professional, “corrects” hearing loss. None of them can do that. They are ‘aids’ that amplify and in some more sophisticated technologies, help clarify speech in some situations. They all can be extremely helpful, depending on an individuals residual hearing, but they do not ‘correct’ hearing loss.

  2. These OTC devices basically have the same features as the sophisticated ones, but lesser algorithms.
    The hearing aids peddled by the Big 6, are marketed to providers with a mark up between 1000% -1500%. If they drop the mark up (greed driven) by half, we can all dispense them at 30% lesser cost to the patients.

  3. Part of me loves OTC when consumers (formerly known as patients) buy a hearing aid and try to operate it. Of course everyone knows that a hearing aid will help but two–thats when our cost conscious consumer (formerly known as a patient) balks. Everyone knows that the greedy audiologists are out to sell two hearing aids! Even with slick marketing from electronics firms I predict monaural sales will skyrocket as consumer satisfaction plummets.That might bring a few more enlightened consumers (that would be called patients) to my office.
    As an audiologist that trained many years and devoted his professional life to working with patients (now called consumers) this is an insult to my professional skills. I don’t sell hearing aids I sell better hearing. RIP audiology

  4. I do not read anything about HEARING TRANSPLANTATIONS—-WHAT’S HAPPENING???
    Has there been any ‘breakthrus’? Will artificial intelligence be of any assistance?

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