A new plan from the FDA to allow hearing aids to be sold over the counter without a prescription is raising concerns among some audiologists and patient advocates. Prof. Nicole Laffan, the audiology clinic director at Northeastern's Speech-Language and Hearing Center, joined GBH’s Morning Edition hosts Paris Alston and Jeremy Siegel to talk about the new regulations. This transcript has been lightly edited.

Jeremy Siegel: Before we get into your thoughts on the FDA's decision, can you break down what exactly does this rule do, as you understand it?

Nicole Laffan: The FDA created two categories of hearing aids. One is prescribed hearing aids, and those are provided by health care providers. And the other one is this new device called over-the-counter hearing aids, or OTCs. And even within the OTCs, there are two categories. There will be non-self fitting and fitting devices. So for patients who decide to move forward and try an OTC aid, they will not receive any professional services.

Paris Alston: Dr. Laffan, let me ask you about the devices themselves. Is there a difference between the one that you would get over-the-counter versus one that you would get if an audiologist or doctor prescribed it to you?

Laffan: Absolutely, a complete difference. So the one that one would get over the counter is a one-size-fits-all. Almost think of this as, have you ever tried different earbuds? Some of them fall out. Some of them just feel sore after a while. Or if you have two in, and you don't like the sound of your own voice, it sounds hollow, you have the occlusion effect. That's what these patients are going to be experiencing. It may or may not have a volume control on it, so a patient may or may not have the ability to make it louder or softer.

It's not custom-designed for the patient's hearing loss. So a patient may have a mild hearing loss in the low frequencies, but then a profound hearing loss in the high frequencies. And that means all of those speech sounds in the high frequencies would be missed. I think the FDA was certainly attempting to provide safe hearing health for patients, but it's doing the opposite. It's potentially causing more risks, more limitations. And I worry about the potential of expanding health inequalities because of this. Because for patients that can afford to go and seek medical advice, they will. And that's just a large concern.

"I think the FDA was certainly attempting to provide safe hearing health for patients, but it's doing the opposite. It's potentially causing more risks, more limitations."
-Nicole Laffan, Audiology Clinic Director, Northeastern Speech-Language and Hearing Center

Siegel: To push back on the concerns that you're expressing a little bit here, advocates say this could be huge for getting people who need hearing aids access to hearing aids. One in eight people in the U.S., tens of millions of people over the age of 12, have hearing loss in both ears. Half of people over the age of 75 have disabling hearing loss. That's a huge number of people. And for someone who may be listening and thinking, 'of course, and audiologist wants people to be using hearing aids that are going to be professionally distributed,' why should someone trust you? Why does that benefit of opening up access to these millions of people not outweigh the risks here?

Laffan: Yeah, great question. So unfortunately, the access that they'll be receiving is poor sound quality and poor-fitting devices, which will then impact their ability to communicate and participate in life. And right now, there's no warranty or return policy. So people will be spending money on devices and unless that changes, they'll be losing their money.

I went into the profession, it's a helping profession. We want to help patients. I want to make a difference. I want them to be able to participate and communicate in social situations, as well as in their work environments. And my concern is that they'll be spending money on these devices that will not provide them what they need.

Alston: At the same time, Doctor Laffan, medical insurance often does not cover hearing aids, and a patient can end up spending thousands of dollars. So is there something else that could have been done to try to make this more affordable and accessible?

Laffan: You brought up a great point about the insurance companies. It's so frustrating. Why are we not lobbying the insurance companies to provide better care, better protection for our patients? It's really unfortunate that individuals pay into insurance and then when it comes to the time that they need this, the insurance companies are not providing the benefit.

"Why are we not lobbying the insurance companies to provide better care, better protection for our patients?"

Siegel: This is set to become a reality potentially as soon as October. What should people know before potentially getting over-the-counter hearing aids? If there's someone who saw this news and is thinking of walking in somewhere and buying them, what should they know?

Laffan: At least start off with a hearing evaluation, so the patient then can know what is my hearing loss? Are there any concerns in terms of the symptoms that I'm experiencing? For safety purposes — if they had a sudden hearing loss, if it's an asymmetric hearing loss, meaning one ear is much better than the other, if they have tinnitus — there are certain symptoms that we would require medical follow up for. Most insurance companies provide care for at least a hearing evaluation. So I would highly recommend that the patient go and have that done.

And then from there, a lot of locations that dispense hearing aids provide complimentary consultations. So at least the patient can gain information from an experienced medical provider about what their needs are. From there, if the patient happened to have a flat hearing loss in the mild to moderate range, maybe then they could potentially go and try that. Professional care and prescribed hearing aids are really what is going to give the best hearing help to any patient.