As of August 16, the FDA gave the final ruling on over-the-counter hearing aids.

OTC refers to hearing aids that can be bought online and in stores. This ruling allows over-the-counter hearing aids to be distributed directly from stores or online retailers without any involvement from a licensed professional.

Their availability is controversial because so many things can go wrong when a consumer self-diagnoses and self-treats their degree and type of hearing loss.

Let’s explore more.

What Are Over-The-Counter Hearing Devices?

An OTC is an over-the-counter device that helps with a hearing loss. The devices are manufactured by both hearing aid-related companies and newcomers to the field.

Over-the-counter hearing aids are defined as instruments that submit the sound through air conduction, which means that the sound is propagated from the device through the air to the ear.

Who Are OTCs For?

The devices are only permitted to be sold to adults —18 years or older — who perceive they have a mild to moderate hearing loss.

They are best for someone who is not yet ready to wear full-time prescription hearing aids but needs a hearing boost in certain situations.

Consequences Of Not Having An Audiologist Treat A Hearing Loss

Bypassing a professional evaluation and going directly to purchasing OTCs can be deadly, and I don’t say that to scare.

There are many risks involved with not going to a professional person to have a hearing loss diagnosed. While you can ignore some simple issues such as earwax in your ear causing hearing loss, you cannot afford to ignore issues such as a middle ear infection or a foreign object in your ear.

Correcting the above with an over-the-counter (OTC) hearing device is like putting a band-aid on an infected wound. Would you ignore a benign growth on the auditory or vestibular nerve? Or a perforation of the eardrum, which can lead to middle ear tumors?

If we are honest with ourselves and can accept that our hearing is not good anymore, we can also acknowledge that treating a hearing loss ourselves is a bad idea because we can’t see the whole picture. Only a professional can assess our hearing health properly.

Can We Self-Diagnose Hearing Loss?

The bottom line is that we’ll never diagnose ourselves as correctly as a professional because we have so many emotions tied to the reality of a diagnosis and treatment. And we tend to see our hearing as being better than it actually is.

So many patients think they only have a mild to moderate hearing loss when it’s actually severe. So many people have the mindset that asking for help signifies weakness. They would much rather buy an OTC than admit a hearing loss or receive a professional diagnosis for it.

But because of a poor self-diagnosis, an OTC likely won’t help their hearing at all, either because the hearing loss is greater than they think it is or because they have a poor ability to understand speech.

OTCs are helpful in certain situations, and I do personally endorse them for the right patient, but there are too many factors to bear in mind when choosing the right hearing treatment.

Going directly to the hearing aids without professional assessment and advice is like buying a basic laptop for $200 with no features when you actually need the top-of-the-line model for your job requirements.

The Best First Step in Determining the Right Hearing Solution for You Is Through a Comprehensive Hearing Assessment.

Why Would Someone Choose An OTC Hearing Aid?

There is no doubt in my mind that distribution of hearing aids is limited at this time because of two things:

  1. There are not enough professional hearing specialists to serve everybody.
  2. People prefer to do things at their own leisure, and they would rather order hearing treatment from home without going anywhere.

There is a need to change this, but I’m not exactly sure that OTCs are the answer.

OTCs at least act like the wedge in the door to make the whole industry think about what we should do to make hearing treatment easier and more accessible. But we need to come up with a better way of enabling wider distribution of prescription hearing aids.

Is it fair to put the burden of buying the right hearing treatment on the consumer? I’m a knowledgeable consumer for some products, but I must admit, I know very little about others.

So I would never purchase something important, even if I thought it would save me some money, without professional input.

To put all the burden of buying hearing aids on the consumer is a little unfair without giving them all the information necessary.

Which is why it makes much more sense to only buy an OTC device after talking about the pros and cons with a hearing professional and getting a proper hearing evaluation.

What’s Good About OTCs?

There are some benefits to buying OTCs:

Easier access: But is “easier” better? Five years from now, we’re going to look at it and either say, “This was a useful thing to do,” or, “This resulted in some negativity toward hearing devices.”


What I’m afraid of is what happened years ago, when hearing instruments were dispensed by anybody who wanted to get in the business of selling hearing aids.

About 40 years ago, I was introduced to somebody who used to paint houses who at one point decided to go into the hearing aid business. The knowledge of this person was less than satisfactory.

Allowing anyone to dispense hearing aids left a black eye on the whole industry for many, many years. People would say, “I purchased relatively expensive hearing aids and they’re in the drawer.” We are still dealing with this issue.

I am just afraid that making OTCs available might result in a similar kind of a situation unless there is a partnership between a professional person and somebody who wants to get an OTC instrument.


Better hearing: OTC devices can boost hearing when needed. The instruments purchased must be something that will really satisfy the need from a personal lifestyle point of view and from a hearing point of view.

Affordability: OTCs are cheaper, with most good devices starting at about $700. We hope this means that people who have delayed any hearing treatment will at least start with something.

Greater awareness about hearing loss: We have yet to see how this plays out.

What’s Bad About OTCs?

  • There are many downsides to buying over-the-counter devices.
  • Risk of great disappointment in the benefits of amplification.
  • Setting us back 30 to 40 years by ignoring the need for medical attention.
  • Risk of inducing increased hearing loss, tinnitus, and hyperacusis due to not being accurately tested.
  • Generic programming that doesn’t meet hearing needs.
  • Ugly devices that don’t fit properly.
  • Ignoring all other brain and health-related issues caused by hearing loss.
  • Ignoring mental health issues such as stress and anxiety, social isolation, and a decrease of confidence in others by not providing prescription-based hearing treatment.

Straining your hearing can be exhausting, but over-amplifying or producing more sounds through some devices creates the risk for tinnitus – buzzing, ringing, and so forth in the ears.

OTCs also exacerbate the risk of hyperacusis, which is oversensitivity to sound. Over amplification, or listening to louder sounds than is clinically necessary, can produce oversensitivity to sound such that normal sound will become intolerable.

Do We Offer OTCs?

At AVI, we are embracing the availability of over-the-counter devices. We’re not rejecting it. We are, however, recommending that any purchase of an OTC device should be done with the help of professionals.

We’re hoping this will afford many more people the possibility of having better hearing and better lives.

We offer a professional service program that will allow the consumer to optimize their use of OTC devices, improving their satisfaction and success with them, with the following services:

  • Consultation regarding various OTC devices
  • OTC device recommendations based on hearing evaluation, lifestyle, and expectations
  • Training on proper use and insertion of a chosen OTC device
  • Various maintenance services for your OTC device

As a full-service hearing clinic, we offer:

  • Full professional audiological diagnosis and evaluation of hearing
  • Examination of the ear canal for earwax management
  • Sale of various OTC devices
  • Sale of 3 to 4 year prescription hearing aid packages

Get a hearing assessment to check your candidacy for OTCs. You can book it via this link.
We are looking forward to getting you started on your hearing journey.

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Dr. Natan Bauman

For more than 40 years, I have had the honor and opportunity of helping thousands of local, national, and international people to achieve a better life through better hearing. As an audiologist and electronic engineer, I have changed the course of the hearing aid industry by inventing the Receiver-In-The-Canal, the most widely used hearing aid in the world. Additionally, I established a tinnitus and sound over-sensitivity clinic and developed a special treatment program which I have been teaching to other practitioners nationally and internationally. Our practice follows the key principles that have defined my career: an adherence to best practices, use of the latest technologies, and personalized care in which the patient is treated as family.

    Norwalk, CT

    (475) 227-0842
    (203) 557-7215

    Hamden, CT

    (475) 227-0842

    Branford, CT

    (203) 291-2929