The Latest on Over-the-Counter (OTC) Hearing Aids

In August 2022, the Food and Drug Administration (FDA) issued its final ruling creating a new category of over-the-counter hearing aids. The goal of the ruling is to make hearing aids more accessible and affordable. This ruling was set in motion in 2017 when the FDA Reauthorization Act directed the FDA to create the new category, but due to Covid-19 and other complications, it has taken five years for it to become a reality.

Over-the-counter hearing aids were recently approved by the FDA. Associated Audiologists continues to investigate these devices to determine the best options for our patients. Dr. Tim Steele discusses OTCs in the video below:

Only one in four adults who could benefit from hearing aids chose to use them, reportedly due to accessibility and cost. Making hearing aids more affordable is a public health priority, especially as the population ages and the number of people with hearing loss continues to grow. Policymakers believe making hearing aids available over-the-counter can improve access to hearing healthcare for adults.

Though this may be a benefit for many people, there are some important points to be aware of, especially if you already wear hearing aids.

OTC hearing aids are intended for adults with perceived mild-to-moderate hearing loss. They are an alternative to prescription hearing aids. Prescription hearing aids will continue to only be available from hearing healthcare professionals, such as audiologists.

However, adults with perceived mild-to-moderate hearing loss who are age 18 or older can now buy OTC hearing aids directly in stores and online. They are not meant for children or for adults who have severe hearing loss or significant difficulty hearing.

OTC hearing aids may help those who have a mild-to-moderate hearing loss. Someone with such a loss usually hears fine most of the time, but might have problems in certain challenging listening situations. Often, family and friends will notice an individual’s hearing loss first and they might say they have to repeat themselves or that the person is turning the TV volume up too loud. Candidates for OTCs also must be 18 years old or older and be capable of fitting the devices themselves.

Those with moderate-to-severe hearing loss, under the age of 18, challenged by learning new things or who have complex health conditions are not candidates for OTC hearing aids.

Most OTC hearing aids run $300-$3,500 a pair. In addition, the individual is responsible for fitting their own hearing aids and servicing them and there is no mandated return policy, so the consumer should understand their options before purchasing.

Individuals who have more severe hearing loss should continue to wear prescription hearing aids that are dispensed and fit by state-licensed, highly trained hearing healthcare professionals, such as audiologists.

These hearing aids are programmed specific to the individual’s hearing loss and provide the higher levels of amplification needed to help someone with a more severe hearing loss. Prescription hearing aids typically include more advanced features such as Bluetooth connectivity and directional microphones.

Prescription hearing aids range in cost, from approximately $1,500 to $6,400 a pair. These costs vary based on the level of technology and features included in the hearing aids. Additionally, a patient who works with an audiologist usually has follow-up appointments and routine check-ups scheduled to monitor how well their hearing aids are functioning and for any changes in their hearing. A return policy is mandated in most states for prescription hearing aids.

Many places may offer OTC hearing aids: pharmacies, big-box stores or online providers. Be aware that if you choose to buy OTC hearing aids, you will make the decision about what you buy, just like any other item on the shelf. You may be able to ask store staff for help; however, these staff members likely do not have specialized training in hearing loss and hearing technology programming. It is important to read all information on the box before buying a device. You may not be able to return the hearing aids once you buy them, and remember, they may cost in the $300-$3,500 a pair price range.

Audiologists, on the other hand, have a doctoral-level degree with extensive training in the ear, hearing, and balance disorders. They can evaluate your hearing, explain your hearing loss and help you consider the hearing aid that is best for you. Some audiologists will also provide OTC devices they have vetted and may be able to help you with basic maintenance of your OTC hearing aids for a separate service fee.

Technically, a hearing evaluation is not required in order to purchase OTC hearing aids. However, it is strongly recommended. In addition, all professional organizations, including the Academy of Doctors of Audiology, the American Speech-Language-Hearing Association and the American Academy of Audiologists, recommend a hearing evaluation before purchasing either OTC or prescription hearing aids.

A comprehensive hearing evaluation is the best way to determine the type and degree of hearing loss and can help you determine which type of hearing aid is the best option for you, OTC or prescription. Without a hearing evaluation, it would be difficult for you to know how severe your hearing loss is and what your best options are.

If you purchase OTC hearing aids in a retail store or online, be aware that you will be responsible for fitting the hearing aids and making sure they work correctly yourself. If you purchase prescription hearing aids from a hearing healthcare professional, they will fit and program your hearing aids, and will provide you with the necessary service and support.

OTC Hearing Aids

Price: $300-$3,500 a pair or less
Age: 18+
Only for: perceived mild-to-moderate loss
Design: one size fits most
Return policy: none mandated by FDA
Selection process: self

Prescription Hearing Aids

Fit by an audiologist
Price: $1,500-$6,400 a pair
All ages, including children
Diagnosed by an audiologist
Best for: all types and degrees
Design: custom with discreet options
Return policy: mandated in most states
Selection process: recommendation from audiologist or hearing instrument specialist

If you currently wear prescription hearing aids that function well for you, you will probably find OTC hearing aids a step down from what you have. In fact, a recent study showed that “premium” prescription hearing aids have the highest user satisfaction. This preference stemmed from factors related to comfort, how the hearing aids processed background noise and how well the study participants could hear speech in a group setting. Because of the lower cost of the technology to develop these features, self-fit OTC hearing aid satisfaction is yet to be fully studied.

The overall life expectancy of hearing aids nationally is around three to four years, especially for hearing aids purchased in big box retail stores. It is anticipated that the life expectancy of OTC hearing aids will be similar, but that is not known yet.

Prescription hearing aids purchased through Associated Audiologists last on average six to eight years.

Why should I see an audiologist, even if I want to buy OTC hearing aids?

An audiologist is the best person to assess auditory function, diagnose hearing loss and provide a medical referral when necessary. They can help you understand why you are experiencing difficulty and determine the type of device that would best suit your needs, which may indicate an OTC device. They can monitor your hearing over time to see if it remains stable or worsens. Regular check-ups are important as further decline in hearing may indicate the need for a stronger prescriptive setting. They can also assess if your chosen hearing aid (OTC or prescription) is providing enough amplification to meet your hearing needs, or whether you and your audiologist should discuss other options. The common goal between you as the patient and the audiologist as the provider is to help you create a plan and a path toward improved hearing.

An audiologist can discuss the pros and cons of OTC hearing aids in Kansas City with you, and whether you may be a candidate for them.

Adapted from materials compiled by the American Speech-Language-Hearing Association and the Academy of Doctors of Audiology, July 2022.