Is this going to make audiologists obsolete?

More than 5 years after the law was passed, the FDA’s ruling about OTC hearing aids was released and we have been fielding lots of questions about it!

Traditionally hearing aids have come in a ‘Bundled” service plan, with unlimited office visits included for an extended period, or even the life of the hearing aids. Hearing aid prices have reflected that, however it was often without adequate explanation that the cost included a significant amount of care.

I believe this made the industry ripe for disruption.

Since the price tag for hearing aids has looked inflated due to the bundled-in care, vendors are now showing much lower prices by simply stripping away much or all of the professional care.

In most cases the cost of OTC devices will only include the devices, or possibly some remote access to adjustments. That will be a significant part of the cost reduction.

Considering ear wax, both in the ears and in the hearing aids, are one of the biggest factors of hearing aid failure, the professional is an important part of the process of treating hearing loss.

I've personally written this article below to give my thoughts on OTC hearing aids after 22 years in private practice. I hope it answers your questions. Since it potentially affects so many people with hearing loss, please forward this on to anyone who could learn from it.

Finally, the FDA rule has been finalized with regulations for what can or cannot now be marketed as a ‘hearing aid’.

Essentially this ruling will create two separate categories of hearing devices:
“OTC” and “Prescriptive”.

There are analogies being made that offering hearing devices over-the-counter will be like when reading glasses were made available over-the-counter. That analogy is accurate in that prescriptive glasses for specific, customized visual needs still need to be fit by an optometrist (or at least with an optometrist’s prescription).

The difference between OTC hearing aids and reading glasses are that reading glasses are simply intended to magnify print or images to make everything larger. It is pretty simple to put on a set of reading glasses and determine if you can read better.

With hearing aids of any kind, magnification of all sounds is not typically helpful as it brings in a lot of background noises. (Even prescriptive hearing aids have had trouble reducing background noise.)

Also, hearing aids take adaptation because we hear with our ears but process in our brains. It is not typically as simple as putting on an amplification device and hearing everything normally.

OTC hearing devices are specifically intended to be used without any help from a hearing professional. They will be marketed to people with self-described mild to moderate hearing loss. They do not require a hearing evaluation to determine type or severity of loss, or if it’s wax impaction or a physical condition that could be medically or surgically treated.

The challenge will be in how people self-diagnose, choose the right product and then self-fit hearing devices.

There are generally two streams of thought when it comes to hearing care. One stream says that some help is better than no help so OTC devices will be appropriate for a large number of people.

The other stream of thought says that due to the relationship between hearing loss and cognitive decline, prescriptive devices are still going to be most appropriate for the majority of people with hearing loss.

After 20 years of providing significant hands-on care, and seeing the consequences of untreated or under-treated hearing loss, I will remain in the stream that believes there will always be a need for the professional to be involved. However, I have also seen the needle stay stuck on low adoption rates or people not getting help because they can’t afford it. I believe that having OTC devices available might move the needle in the right direction. However, here are some of my thoughts.