FDA Finally Approves Guidelines for OTC Hearing Aids!

Over the counter Hearing aids

Recent FDA rule changes regarding Hearing Aids

The press release says:  “FDA Finalizes Historic Rule Enabling Access to Over-the-Counter (OTC) Hearing Aids for Millions of Americans.”

Isn’t that great?  This is a new change several years in the making.

You will recall that Congress passed a bill in 2017 requiring the FDA to create a category of Over-the-Counter (OTC) hearing aids.  This is the final step in that process.

Consumers could see OTC hearing aids in stores or online retailers in October.   The rule is expected to lower costs.  It is designed to assure the safety and effectiveness of OTC hearing aids while fostering innovation and competition in the hearing aid technology marketplace.

These are still considered to be medical devices and can only be sold to those 18 and older.

No prescription, no medical exam, no fitting is required, and no licensed seller is required.  It is to be marketed to those adults who believe they have mild to moderate hearing loss.  “Consumers with perceived mild to moderate hearing impairment”, according to the FDA’s press release.

At first glance, these OTC hearing aids appear to be a good thing.

For some, I am sure that will be the case.  For anyone who has gone through the process of purchasing hearing aids with the assistance of an audiologist, you are probably wondering how it could be done safely.  Between 2017 and now, the FDA did listen to a few experts.

There are limits to the depth these OTC aids go into the ear.  They lowered the maximum sound output and put in user-adjustable volume controls.  They also simplified the phrasing in the instruction manual that will come with the device.  There will be apps and there will be videos and other helpful hints.

Can a person self-diagnose a hearing loss?

Well OK, but…I am stuck at the “perceived mild to moderate hearing impairment”.  How can a person possibly know that?  I would not be surprised if most people out there don’t know someone who denies their hearing loss; blames it on people who mumble, or talk too loud, maybe agrees to some loss but insists it is not too bad.  Now people are going to admit to a hearing loss, figure it is mild to moderate and go to a store to buy a hearing aid!

Hopefully, that person will go to a hearing care professional and get a diagnosis before buying a product to ensure it will work for them.  I guess worst comes to worst they can return it if it comes at no benefit.  And it is only money if it doesn’t work.

There are a plethora of reasons why it may not work unless you get the help of course.

Buying hearing aids over the counter is not, however, like buying a pair of “readers” at the local pharmacy.  These are little computers you are putting in your ear; the process is far more nuanced.  Hearing loss is rarely the same across all frequencies.  Hearing aids are not a “one size fits all” device.  That is why the audiologist or hearing aid dispenser goes through an adjustment period with you and your new aids.  Here there is no exam so no way to diagnose potential structural issues within the ear, or with the auditory nerve.

We are happy for those who will be helped by this and we are standing by to help you be successful with your purchase of an over-the-counter hearing aid.

That is great, especially if they can save a little money while improving their hearing.  Great!  What about all the people this does not help?  It does not help children.  It does not help those with a more severe loss.  We all know how important it is to hear.  That is how we communicate with our environment and those around us.  What happens when someone buys one of these and it is not helpful?  He or she is not going to be anxious to spend more.

Is this a cop-out for insurance not covering hearing aids?

No one denies that many more people could benefit from wearing a hearing aid than are currently wearing one.  The FDA thinks that about 30 million Americans could benefit from wearing one, yet only about 20% of those who need one, actually wear one.  The reasons vary such as access to care (especially in rural areas), and costs and there is still a stigma.  We believe that the stigma may be more of an influence on not getting a hearing aid than the cost.

We hope congress does not dust off their hands and think they are done with this topic.  They are not done until Everyone who needs hearing aids can be seen.  That is what we at Hears Hearing & Hearables work to bring about the right change.

Happy Hearing for All!

Written by Karen (edited by Kim)

I took information for this summary/opinion page from the FDA, and associated pages:




P.S. NOTE:  We will be keeping everyone abreast of the new OTC hearing aids as they become available and our thoughts about them.  We hope to help you and we hope you will buy them from us.  We want you to be successful too.

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