On October 17, 20221, The FDA issued its final approval allowing Over-the-Counter (OTC) hearing aids to be sold directly to consumers without a licensed professional. You may wonder how this change will impact the people with hearing loss or the hearing aid market as a whole. The answer is simple; consumers now have more choices to address their hearing loss needs.

Hearing loss is complex and no single solution will meet every person’s needs. The introduction of OTC hearing aids allows for additional solutions for those experiencing hearing loss.

Know your options

Know your options

The key to choosing your best solution is understanding your needs and the difference between OTC and prescription hearing aids. Let’s start by defining those solutions and who they are intended to help.

OTC Hearing Aids

The FDA defines OTC hearing aids as a self-fitting hearing aid that is a medical device designed to treat perceived mild to moderate hearing loss in adults 18 years and older1. OTC hearing aids are limited in the amount of amplification and adjustment capabilities to ensure ease of use and safety for the consumer.

What does that mean to you? If you are over 18 and perceive your hearing loss as mild or moderate, you may purchase an OTC hearing aid without a prescription. OTC is not right for you if you have a history of medical conditions with your ears, if you perceive a moderately severe hearing loss, or if you want more precision in adjustments.

In a nutshell, an OTC candidate:

  • Hears well in quiet environments but struggles with noise.
  • Owns and is comfortable using a smartphone and using smartphone apps.
  • Enjoys learning new things and is comfortable with technology.
  • Is interested in addressing their hearing loss but does not want to engage with the traditional hearing aid process.

Prescription Hearing Aids

The FDA requires children under 18 years of age, those with medical conditions of the ear (tinnitus, drainage, pain, etc), and those with moderately severe or greater hearing loss to seek Prescription hearing aids.

Prescription hearing aids differ significantly from OTC hearing aids. There are two critical differences. First you will work with a highly skilled, licensed hearing care provider who will provide the highly detailed prescriptive settings for the hearing aid, and the coaching and counseling you require to achieve your best results. Second, the technology in prescription hearing aids is much more advanced allowing greater flexibility and customization to meet your unique hearing needs.

With these enhancements, you and your provider together will be able to measure your results and ensure the best rehabilitation for your hearing loss and ensure that your hearing needs are being fully met with the solution.

If you have hearing loss and are experiencing an ear medical condition, like Tinnitus or ringing in your ears, prescription hearing aids can help alleviate the symptoms while helping you to hear better.

This comparison chart below (fig. 1) provides a quick glance at the different technology and profiles between OTC and Prescription hearing aids.

Your first step!

The first step in understanding which type of hearing aid is right for you is knowing and understanding your degree of hearing loss. You do not need a hearing test to purchase OTC hearing aids. But knowing more about your hearing is beneficial to making the right choice to ensure a great outcome and avoiding the loss of time and money on the wrong solution.

You have options for online screenings or an in person hearing evaluation.

Hearing Screening

Online hearing screenings are usually free, quick, and easy – AND reliable!

Screenings give you a good gauge of which type of device you should consider. The screening measures how loud each pitch needs to be for you to hear it.  The best screening accuracy will happen in a quiet environment. So, find a quiet spot to perform the screening and use over the ear headphones or earbuds. Follow this link to use the online screening tool.

In-Person Hearing Test

The most thorough option is an in-person hearing evaluation. The in-person evaluation includes time with a highly trained hearing care provider. The Hearing Care Provider (HCP) will help you examine your current lifestyle to determine:

  • Your unique listening needs,
  • Your activity level in various environments,
  • Environments where you excel,
  • Environments where you struggle,
  • Your physical ability to use different styles of hearing aids,
  • Your preferences for technology, etc.

The provider will perform a physical examination of your ear canal identifying wax and other possible abnormalities. The testing is more detailed than the screening checking your ability to hear a larger range of pitch, evaluating your auditory nerve pathway’s ability to recognize speech sounds, and your ability to separate noise from your desired speech signal.

Want to know more about what to expect at your in person appointment?

Making the right choice

Making the right choice

To make an informed decision, we recommend you get your hearing tested by a Hearing Care Professional to learn and document your unique hearing needs. Based on the results and your preference, you can purchase OTC hearing aids or prescription hearing aids.

If you prefer to avoid having an in-person consultation, you can take an online hearing test here, to help determine your degree of hearing loss and learn if OTC is right for you.

Whatever you choose, DON’T WAIT! Avoidance can have a negative impact on your health-related quality of life2. Instead, Take Charge of your hearing health. Start with a hearing test, then make the right choice based on your needs and lifestyle to Hear Better Today!

 

Sony OTC CRE-C10

Sony OTC CRE-E10

Essential Technology

HearTech Technology

HearTech Advanced Technology

HearTech Elite Technology

Prescription & hearing test required

 

 

X

X

X

X

Over-the counter, no hearing test required

X

X

 

 

 

 

Level of Hearing loss

 

 

 

 

 

 

Slight

X

X

X

X

X

X

Mild

X

X

X

X

X

X

Moderate

X

X

X

X

X

X

Severe

 

 

 

 

X

X

Profound

 

 

 

 

X

X

Style and fit

 

 

 

 

 

 

Behind-the-ear (BTE)

 

 

X

X

X

X

In-the-ear (ITE

X

X

X

X

X

X

Limited colors

X

X

 

 

 

 

Variety of colors

 

 

X

X

X

X

Self-fit, self-supported

X

X

 

 

 

 

Personalized Fit & supported by an audiologist

 

 

X

X

X

X

Features

 

 

 

 

 

 

Non-rechargeable batteries

X

 

X

X

X

X

Rechargeable battery

 

X

X

X

X

X

Bluetooth connectivity

 

X

X

X

X

X

Smartphone Connectivity

X

X

X

X

X

X

Directional microphones

 

X

X

X

X

X

Programmed to your needs & as hearing changes

 

 

X

X

X

X

Advanced noise reduction

X

X

 

X

X

X

Health and step trackers

 

 

 

 

 

X

Sound Environments

 

 

 

 

 

 

Watching TV

 

 

X

X

X

X

One-on-One Conversations

 

 

X

X

X

X

Small Group Conversations

 

 

X

X

X

X

Small Gathering

 

 

 

X

X

X

Lecture/Religious Service

 

 

 

X

X

X

Shopping/Public Places

 

 

 

 

X

X

Restaurant or Party

 

 

 

 

 

X

Concert/Event

 

 

 

 

 

X

Maximum Hearing Profiles

4

6

Maximum Hearing Channels

5

9

17

64

  1. Commissioner, Office of the. “FDA Finalizes Historic Rule Enabling Access to over-the-Counter Hearing Aids for Millions of Americans.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans.

  2. Johnson, Carole. “The Early Intervention of Hearing Loss in Adults.” Seminars in Hearing, vol. 39, no. 02, 2018, pp. 115–122., https://doi.org/10.1055/s-0038-1642616.