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It has been a little more than 8 months since the FDA issued its final rule for making hearing aids available over the counter (OTC). So how are things going these days in the OTC hearing aid market?

In the audiology world, anecdotally, it appears that not much has changed, said Lindsay Creed, AuD, associate director for audiology practices at the American Speech-Language-Hearing Association in Rockville, Maryland.

Little Change in the Status Quo

"We talk to our members on a daily basis -- they are audiologists that practice in a range of settings across the country," she said in a phone interview. "And they're not reporting a huge change in the status quo compared to before OTC hearing aids were available for sale."

However, she added, "We are thinking that a lot of the customer base for OTC hearing aids are not actually the patients that would have gone to an audiologist in the first place." Instead, "they are those individuals that are maybe just starting to notice that they have some hearing loss or for other reasons aren't ready to go see an audiologist or another hearing care professional. So they're choosing to pursue OTC [aids], and they're not necessarily showing up at the audiologist's office yet."

One practice, Mass Eye and Ear, is taking the bull by the horns. "Audiology here is selling and recommending over-the-counter hearing aids to some patients," said David Jung, MD, PhD, of Harvard Medical School in Boston, with which the hospital is affiliated. "Our audiologists very early on took the stance strongly that 'these are coming; it's not up to us, so I think we're better off offering them and offering programming in case patients can't get fit appropriately at home.' That makes sense to me."

"My impression has been that they're recommending these [OTC hearing aids] to patients who are relatively straightforward -- they don't have severe loss or some strange pattern of hearing loss that would require more intervention or more programming with an audiologist," he noted in a phone interview.

Pros and Cons of "Self-Fitting" Devices

In addition, the Mass Eye and Ear audiologists are usually recommending a "self-fitting" OTC ReSound device that the patient can customize at home without professional help for around $800 a pair. While not inexpensive, prescription hearing aids can cost up to about $6,000, Jung noted.

However, business isn't exactly booming, said Jung. "The audiologists told me [sales] volume has been quite low; in the past 2 months they've sold six pairs, with a 50% return rate."

The OTC market presents consumers with several choices, said Nicholas Reed, AuD, assistant professor of epidemiology at Johns Hopkins University in Baltimore. Although all OTC hearing aid manufacturers have to register their devices with the FDA before putting them on the market, the agency isn't really collecting data on how well they work. However, manufacturers of self-fitting devices "have to do a clinical trial, and they have to actually prove that somebody can use their device about as well as an audiologist and really succeed," he said. "That's very powerful."

On the other hand, the self-fitting devices are more complicated to use than other OTC hearing aids that have "pre-set" levels for patients to choose from, said Reed.

How to Advise Patients

So how should doctors advise patients who are thinking about getting OTC hearing aids?

"The way I work this through with anybody that asks me, the first question I'm asking them is, 'Could you right now -- right in front of me -- grab your smartphone and figure out how to update the system if it were out of date?'" Reed said. "If you can't figure out how to work the smartphone, then maybe OTC is not going to be a great angle for you, because it's complex. Hearing care is not some simple 'switch a button and you're done'-type thing."

But for patients who do go with OTC aids, "I would very much recommend to patients that they look for self-fitting OTC hearing aids because there's that extra layer of regulation," Reed said. "At least we know that clinical trials have been done on those devices."

For those patients who aren't as good with updating their phones, "then I've been suggesting that maybe before they jump into the OTC market, they should talk with a professional," he added. "One of the misnomers that's out there is that OTC means that no professional has to be involved. But that's not true at all." For example, he said, "I call my toddler's physician, and they tell me to give him Tylenol. It's an OTC drug, but I [used] it at the discretion and instructions of a professional."

"Just because an audiologist isn't selling you a device doesn't mean that the two couldn't work hand in hand," he continued. "In fact, in my view of the world, that's actually a better world ... I don't actually believe that healthcare professionals should be selling you anything. It should be regulated somewhere else, and then they provide their services."

Reasons for Excitement

U.S. consumers should be excited about this new category of hearing care, according to Karina De Sousa, AuD, of the University of Pretoria in South Africa. De Sousa and colleagues recently authored a that found that of 64 adults with hearing loss, self-reported and speech-in-noise benefit was equivalent between the self-fitting OTC and audiologist-fitted hearing aid at the end of 6 weeks.

"The findings of this study show that good quality self-fitting OTC hearing aids, coupled with decent online support, can produce reasonable satisfaction and outcomes for people who qualify to wear them," De Sousa said in an email. However, consumers need to weed out the good products from the bad, she said, noting that some of her colleagues have developed a that might be useful.

In the end, the OTC market might actually benefit audiologists, said Creed. "Most audiologists that you talk to, they have wait lists of patients waiting to come in. So it's not like they're necessarily worried about OTC hearing aids changing their practice drastically. We can't even serve all the patients that we want to at this point."

Instead, Creed predicted, the OTC market "is going to be an impetus for, hopefully, recruiting more people into our field, and we can ultimately service more people."

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