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Have you heard about the new Over the Counter Hearing Aid (OTC) Act? Let us fill you in.

Sarah Sydlowski, Audiologist and President of the American Academy of Audiology breaks it down; your hearing connects you to other people so trust an audiologist to help you find the right device for your hearing needs.

What Are OTC Hearing Aids?

*Article provided by The American Academy of Audiology

Over-the-counter (OTC) hearing aids are devices that make sounds louder. OTC hearing aids:

  • Are approved for adults 18 years of age and older

  • Are indicated for individuals with perceived mild to moderate hearing loss

  • Are available in stores or online and the consumer is responsible for setting up the device, including fitting and tuning the sound

  • Do not require a hearing exam or prescription from a physician or a hearing-health-care professional

OTC hearing aids are meant to be less expensive than professionally fitted hearing aids...for a reason!

Reasons for this lower cost include: OTC devices possess lower technology, OTC are not custom fit to the ear and hearing loss, and consumers are buying only the device and not purchasing any professional services such as hearing testing or professional counseling on the use of the device. Current estimates are that OTC hearing aids will cost between $300 and $600 per device.

Why Are Hearing Aids Being Offered Over the Counter? The Food and Drug Administration (FDA) Reauthorization Act of 2017 directed the FDA to establish and develop regulations for a class of OTC hearing aids in response to demands by consumers and other government agencies for affordable and accessible hearing aids in the United States. The FDA is in the process of finalizing regulations that will apply to this new class of amplification devices. These rules will include the following:

  1. How loud these devices can be,

  2. What labeling will be required on the outside and inside of the box that these devices come in, and

  3. What requirements are related to the sale of these devices.

What is the benefit of having OTC hearing aids available?

Studies show that the average person waits 7–10 years after first experiencing symptoms before seeking professional hearing help. Studies also link untreated hearing loss with an increased risk of depression, falls, and earlier onset of decline in thought processes. One goal of OTC hearing aids is to provide more timely access to lower-cost hearing aids. OTC hearing aids may be a good first step in getting people situational hearing help earlier; however, when individuals need a more customized solution, have complex medical needs (e.g., difficulty using hands or problems with thought processes), or have an increasing degree of hearing loss, they need to involve an audiologist to create a comprehensive plan of care.

Who Is a Good Candidate for OTC Hearing Aids?

OTC hearing aids are approved for use only in adults 18 years of age and older who have mild to moderate hearing loss. It is advised that individuals receive a hearing test from an audiologist to find out the level of hearing loss and know that they are candidates for this type of hearing aid. However, because a hearing test is not required, individuals could instead consider the following questions to identify mild to moderate hearing loss:

  1. Are you able to hear easily in quiet, one-on-one situations?

  2. Are there a few difficult listening situations where you think you would want to wear the OTC hearing aids as opposed to feeling like you would need it in most communication situations?

  3. Does turning up the volume on the phone or TV just slightly help you hear better (this level might be considered a little loud by others but not extremely loud as opposed to needing to turn these devices up quite a bit to a level that bothers others)?

If you answered yes to these questions, you may have mild to moderate hearing loss. People with more severe hearing loss have difficulty in these situations as well, but they have difficulty more consistently across many situations as identified by themselves or by those around them. OTC hearing aids require that the user can follow instructions to fit the device to their ear and tune the sound of the device. An automated hearing test that requires responses to sounds may be offered. The process also could include managing a volume control or app-based program that has the user change the bass (low pitches) and treble (high pitches) to find a sound combination that seems to be helpful.

Can Children Use OTC Hearing Aids? No. OTC hearing aids are approved only for individuals 18 years of age and older. Due to the medical nature of childhood hearing loss and the importance of accurate sound delivery for the developing brain, OTC hearing aids are not appropriate for children.

Audiologists serve as vital members of health-care teams in treating children with hearing loss to ensure best outcomes. Plan to see an audiologist if you are concerned that your child has hearing loss.

What Concerns Exist Regarding OTC Devices? Professional services before, during, and after hearing aids are fit may not be available for OTC hearing aids. An audiologist is a doctoral level professional, who is trained to evaluate hearing, diagnose hearing loss, and help optimize hearing health and communication through safe and effective use of all hearing aids, including those available OTC when indicated. Audiologists also counsel individuals about the appropriate care and use of hearing aids, realistic expectations, and benefits and risks associated with the use of either OTC or prescription hearing aids. Basic hearing tests may be found online or through smartphone apps. Self-guided hearing tests should be used with caution. When the audiologist is removed from the diagnostic process, ear conditions that require medical attention can be missed. If a difference in hearing between ears is obvious, or symptoms like pain or drainage from the ear are present, please see a physician or audiologist before proceeding with an over-the-counter hearing aid.

No matter what type of hearing aids you choose to try, an audiologist can help ensure you get the most out of them. The audiologist can also ensure all your hearing healthcare needs are addressed over time as your hearing or the demands on your hearing change.

Key Differences

Prescription Hearing Aids

OTC Hearing Aids

Who Fits Them?

Licensed audiologist or hearing instrument specialist

Self-fit, ordered online or purchased in store


$1200-$7000 per set

Likely less than $2000 per set

Diagnosis and testing?

Conducted by medical professional with advanced testing and diagnostic tools

Approximated by self, depending on product purchased


Full range, including discreet custom options

Limited; one size fits most

Degree of Hearing Loss?

Diagnosed mild to severe/profound

Self-perceived mild to moderate

Intended User?

Any age, any medical status

18+, best for those without complex ear conditions (see below)

*Complex ear conditions include:

  • Unilateral (one-sided hearing loss)

  • Sudden recent hearing loss

  • Ringing, roaring or beeping in one or both ears

  • Take or have taken medication known to cause hearing loss

  • Have a history of chemotherapy or radiation in head/neck area

  • Have constant pain in ears

  • Have frequent dizziness

OTC Hearing Aid Frequently Asked Questions With all of the new information coming out about OTC hearing aids, it's normal to have questions. Below are some commonly asked questions about OTC hearing aids. If you have a question that isn't on this list, feel free to reach out to your local audiologist.

  • The proposed regulations from the FDA do not require that OTC hearing aids be returnable but state that device packages need to include the return policy of a device. If you have not had a hearing test and are not sure that you are even a candidate for OTC hearing aids, you may want to select a device that can be returned in case you do not see a benefit from the device.

  • OTC hearing aids are considered “self-fitting,” which means that the consumer controls the settings and that no hearing-health-care professional must be involved. Devices may come with controls that allow for adjustments to volume or may be programmed by the user with a smartphone app.

  • A wide variety of OTC hearing aids are expected to come onto the market. You can get a hearing test with an audiologist and discuss possible OTC hearing aid solutions. The audiologist will be familiar with these products and can provide assistance. Without the assistance of an audiologist, you will want to research the various options available and consider what you want from the product. You may find online reviews that are helpful as these products are used by other consumers and they report on their experience. You will want to look for a device that can be returned in case you find it does not meet your needs.

  • Once FDA regulations are finalized, OTC hearing aids will be advertised and sold in local drug stores, big-box stores, online, via mail, and even in an audiologist’s office.

  • Manufacturers and distributors will set the price of any device, but OTC hearing aids are anticipated to be between $300 and $600 per device.

  • There should be a customer support, toll-free number and web address included in the packaging of the OTC hearing aid that you purchase. An audiologist can also provide general guidance and programming for OTC hearing aids. In addition, an audiologist can perform a hearing evaluation and measure the output of an OTC hearing aid to determine if it is appropriate for you. You can find an audiologist in your area and ask if they offer these services. Office visit fees may apply as insurance does not always cover hearing aid services.

  • If you have significant hearing loss or have any of the symptoms listed below, you should not purchase an OTC hearing aid without first seeing an audiologist or ear, nose, and throat physician. The following symptoms are examples of medical issues that should be evaluated before considering OTC hearing aids:

  1. Malformed or misshapen ear at birth or due to trauma

  2. History of drainage from the ear within the previous 90 days

  3. History of sudden or rapidly progressive hearing loss within the previous 90 days

  4. Dizziness just experienced or experienced over a long time

  5. Hearing loss in only one ear or sudden or recent onset of hearing loss within the previous 90 days

  6. Significant ear wax accumulation or a foreign body in the ear canal

  7. Pain or discomfort in the ear

Seek medical advice if any of the above symptoms occur after using an OTC hearing aid.

  • The most common hearing loss in adults comes on gradually. Individuals often do not identify the level of their hearing loss accurately because of these gradual changes over time. This makes it difficult to identify accurately if you are a candidate for OTC hearing aids (someone with a mild to moderate hearing loss). A hearing evaluation can help you be confident that you are a candidate. Hearing tests provided by an audiologist are typically covered by health insurers, but check your coverage specifically. The audiologist uses information about your lifestyle and listening needs, as well as the results from your hearing test, to create the best treatment plan for you. This plan includes what type of devices are recommended. Choosing a hearing aid may seem straightforward, but a lot of information goes into making the best choice for an individual.

  1. The degree of hearing loss, ear canal characteristics, and individual preferences will all impact the recommendation of style (what the hearing aid physically looks like).

  2. The individual’s lifestyle and communication demands help determine the technology and features (how the hearing aid functions and how automatic it is) to select and program in the hearing aid fitting.

Because adult hearing loss comes on gradually, the individual’s brain is used to listening through the hearing loss and considers that input “normal” even though sound is being filtered by the hearing loss. The brain thinks that is normal, and it is difficult for individuals to judge how much amplification is needed when they try hearing aids. Typically, people have different amounts of hearing loss at different frequencies, which complicates the hearing aid selection process. In fitting a hearing aid, the audiologist puts a microphone in the person’s ear canal to measure the amplification provided by the hearing aid for different types of sounds. This allows the hearing aid to be tuned correctly for the person’s hearing loss and ear canal and ensures that loud sounds will not damage the user’s hearing. On the first day of the hearing aid fitting, most patients indicate that sounds do not seem normal to them, and that is because the brain is not used to hearing many of the softer sounds. On average, it takes several weeks of full-time use (all waking hours) to adjust to a new hearing aid fitting because the brain must adapt to this new normal. Without these measurements, it is impossible to know if the amplification device has been set optimally for the individual. If you go with an OTC hearing aid and do not feel that you are receiving the benefit you expected, you may want to see an audiologist who can make these measurements in the ear canal and provide you with advice about how to reset the device if it has controls on it for fine-tuning. You would expect to pay an office visit fee for these services, which are not typically covered by insurance. Remember, if you are engaged in loud activities and are exposed to loud sounds over time, your hearing can be damaged. If you are concerned that your hearing has changed, you may want to see an audiologist for an updated hearing test.

For any other questions, make an appointment with one of our Doctors of Audiology!


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