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Over-the-Counter (OTC) and Prescriptive Hearing Aids: the Differences Between the Two Categories and What It Means for Consumers

In August 2022 the U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) hearing aids for consumers ages 18+ who have perceived mild to moderate hearing loss. Now these individuals have affordable options and easier access to hearing aids as there is no need for a hearing exam or prescription. Beginning October 17, Lucid Hearing’s OTC hearing aids will be available in various retail outlets including Sam’s Club and Best Buy, online through Amazon, or at lucidhearing.com.

OTC FAQ
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Millions of Americans are affected by hearing loss

Many of those with perceived mild to moderate loss have never done anything to hear better, mainly due to cost and the exam and prescription requirements. Before the FDA ruling, the only available OTC products were personal sound amplification products (PSAPs). While hearing aids and PSAPs both amplify sound for the user, the products have different intended uses. Hearing aids are intended to make up for impaired hearing. PSAPs, in contrast, are intended for people without hearing loss to amplify sounds in certain situations, such as recreational activities like birdwatching. Now OTC hearing aids will offer exceptional solutions for perceived mild to moderate impaired hearing, but more affordably and without the need for an exam or prescription.

It is estimated that one in eight people, twelve years and older, in the United States experiences hearing loss in both ears. These individuals can have difficulty engaging in and understanding everyday communication. FDA commissioner Robert M. Califf, M.D., believes, “establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

Degrees of Hearing Loss

The Centers for Disease Control and Prevention (CDC) describes a person’s degree of hearing loss as follows based on a range from “mild” to “profound”.

  • Mild – May hear some speech sounds but soft sounds are hard to hear
  • Moderate – May hear almost no speech when another person is talking at a normal level.
  • Severe – Hears no speech when a person is talking at a normal level and only some loud sounds.
  • Profound – Will not hear any speech and only very loud sounds.

Deciding if OTC Hearing Aids are Right for You

Most individuals are reluctant to schedule an appointment with an audiologist in an effort to save time and money. Now there are two perks consumers can rely on when it comes to the new category of OTC hearing aids: accessibility and affordability. With no required testing or evaluations for OTC hearing aids, the FDA ruling is intended to drive competition within the market for more innovative and cost efficient options for consumers. The FDA recommends OTC hearing aids for individuals 18+ with perceived mild to moderate hearing loss. Common signs of hearing loss within this range include muffled sounds, continuous need to ask people to repeat themselves, trouble hearing in noisy atmospheres, and listening to the TV at a higher volume than preferred by others.

While not required, getting a hearing test is still recommended for anyone who may have impaired hearing because specialists are able to accurately determine your exact level of loss and assist you in finding the right product and right fit – whether that means an OTC hearing aid or a prescription device. While OTC hearing aids do not require a medical examination for purchase, if you are experiencing any of the following: sudden hearing loss, ear pain or discomfort, any drainage from the ear, it is our recommendation that you check with your physician or see an audiologist or licensed hearing instrument specialist for an evaluation to determine if an OTC product is right for you. Lucid Hearing offers free exams in its hearing centers. Schedule an appointment online or call (800)785-6052.

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Prescription Hearing Aids

The primary difference between OTC and prescription hearing aids is the level of hearing loss they can support.

With prescription hearing aids, any individual with mild to profound hearing loss can benefit from a hearing aid customized for the support they require. If your hearing loss is severe or profound, you can benefit greatly from prescription hearing aids. While this category of hearing devices does require you to go through a hearing test, the test itself is easy and painless, and in many cases, can be done free of charge (like at Lucid Hearing centers available nationwide). A hearing specialist will review your test results with you and advise you on the type of hearing aid best suited to support your hearing loss, lifestyle and preference.

Styles of Hearing Aids

For both OTC hearing aids and prescriptive devices, styles can include:

  • Behind-the-ear – Generally the most common hearing aid style and can be used by people of all ages. A plastic case containing most of the electronics sits behind the ear and is connected to a speaker or tube that fits in the ear canal
  • In the ear – Sits completely in the outer ear (the “bowl” of the ear) and all the electronics are housed in a small shell.
  • In the ear canal and completely in the canal – These are the smallest hearing aids currently available, and the electronics are contained in a small discreet shell that fits partly or completely in the ear canal.

Some people want to be as discreet as possible about their hearing aids, so in-the-ear devices may suit them best. Others may not want to have an object in their ears, so behind-the-ear hearing aids might be their preference. Either way, there are many styles and colors to choose from now when it comes to hearing aids. Lucid Hearing has a comprehensive portfolio of affordable hearing aids.

Hearing Aid Features

In addition to having a variety of styles to choose from, OTC and prescription hearing aids offer a variety of features. Here are a few features available currently, depending on the product:

  • Directional microphones focus on sound from a specific direction. They can help you hear someone in a face-to-face conversation over the noise around you, for example.
  • Telecoils enable the hearing aid to pick up sound directly from compatible phones or compatible sound systems in public places.
  • Wireless connectivity such as Bluetooth allows hearing aids to interact with our Lucid Hearing App featuring LucidShape® for personalized settings and to stream audio from your IOS or select Android mobile device (compatibility required).

Some people want to be as discreet as possible about their hearing aids, so in-the-ear devices may suit them best. Others may not want to have an object in their ears, so behind-the-ear hearing aids might be their preference. Either way, there are many styles and colors to choose from now when it comes to hearing aids. Lucid Hearing has a comprehensive portfolio of affordable hearing aids.

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Sources

U.S Food & Drug Administration. (2022) FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans (https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans)

Centers for Disease Control and Prevention. (2022) Types of Hearing Loss (https://www.cdc.gov/ncbddd/hearingloss/types.html)

U.S Food & Drug Administration. Hearing Aids and Personal Sound Amplification Products: What to Know (https://www.fda.gov/consumers/consumer-updates/hearing-aids-and-personal-sound-amplification-products-what-know)

National Institute on Deafness and Other Communication Disorders. Quick Statistics About Hearing (https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing)

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