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What To Know Before Buying Over-the-Counter Hearing Aids

March 3rd is World Hearing Day, an international observance dedicated to raising awareness of ear and hearing care established by the World Health Organization. This year’s theme, “Ear and hearing care for all!” emphasizes the importance of hearing health education and access to care for the millions of people with hearing loss worldwide.

To commemorate World Hearing Day, Focus spoke with Meaghan Reed, AuD, CCC-A, director of Clinical Audiology at Mass Eye and Ear, to talk about over-the-counter hearing aids, a new category of hearing devices that can be purchased directly by consumers without the need for a medical exam, prescription or professional fitting.

Meaghan Reed, AuD, CCC-A, fits a patient with a hearing aid at Mass Eye and Ear.
Meaghan Reed, AuD, CCC-A, fits a patient with a hearing aid at Mass Eye and Ear.

New law spurs new access for hearing aids

Over-the-counter (OTC) hearing aids are defined by the Food and Drug Administration (FDA) as medical devices designed to treat perceived mild to moderate hearing loss in adults aged 18 years and older. Until very recently, hearing aids were available only by prescription from an audiologist or other hearing health professional. Following a law first passed by Congress in 2017, the FDA formally created a new category this past summer for hearing aids that can be purchased directly by consumers both online and in stores where health care devices are sold, such as pharmacies and stores like Best Buy or Costco. These OTC hearing aids began to hit store shelves in October 2022.

Like prescription hearing aids, OTC hearing aids make sounds louder so that people with difficulty hearing are better able to listen, communicate and participate in daily activities. OTC hearing aids are also regulated as medical devices by the FDA, which helps ensure they meet specific safety and efficacy regulations in order to be marketed as OTC hearing aids on store shelves.

According to the National Institute on Deafness and Other Communication Disorders, nearly 25 percent of Americans between the ages of 65 and 74 have hearing loss severe enough to affect their daily lives. That number jumps to 50 percent for people over the age of 75.

Research also indicates that hearing loss can impact a person’s physical and emotional wellbeing. “We know that untreated hearing loss leads to social isolation and loneliness, especially in older adults, and is associated with cognitive decline,” said Dr. Reed.

Despite the significant burden of hearing loss, people wait an average of 10 years before buying hearing aids. The reasons for this delay range from underestimating one’s level of hearing loss and avoiding the stigma of wearing a visible hearing device, to lack of access to hearing aids and concerns about cost.

“The thought was that by providing an OTC hearing aid, it would improve both the accessibility and affordability of hearing devices to help address these unmet needs that we’re seeing,” said Dr. Reed.

One size does not fit all

Although OTC hearing aids are more accessible than prescription devices, they are not for everyone, and there are several factors a person should consider before making their choice, according to Dr. Reed.

OTC hearing aids are designed to treat mild to moderate hearing loss, and do not have enough amplification to meet the needs of someone with moderate to severe or profound hearing loss. How can one know the difference? “Someone with mild to moderate hearing loss will have difficulty hearing in noisy environments, like a crowded restaurant or train station, or when the speaker is a distance away,” said Dr. Reed. “If someone struggles to hear in one-on-one conversations in a quiet environment, they likely have hearing loss that should be evaluated by an audiologist for a prescription hearing aid.”

Additionally, all OTC hearing aids are not alike. There are two types—self-fit and non-self-fit. Self-fit hearing aids are equipped with a built-in hearing assessment that enables the user to determine their threshold level of hearing, leading to a prescribed hearing aid setting and the ability to fine-tune. Non-self-fit hearing aids have preset volume levels from which the user can choose, and are not necessarily tailored to a person’s individual hearing needs. It is important for users to know which is which when purchasing OTC hearing aids and to manage their expectations accordingly.

When to see an audiologist

Audiologist Meaghan Reed conducts a hearing assessment of a patient at Mass Eye and Ear.
Audiologist Meaghan Reed conducts a hearing assessment of a patient at Mass Eye and Ear.

While someone with moderate to severe or profound hearing loss should be evaluated by an audiologist for a prescription hearing aid, there are also other circumstances where OTC hearing aids are not recommended no matter the level of hearing loss. People should instead seek a medical evaluation for:

  • Hearing loss in one ear or that is noticeably different in each ear
  • Tinnitus (ringing) in one or both ears
  • Sudden or quickly worsening hearing loss
  • Pain or discomfort, or suspicion that something is lodged in the ear canal
  • Infection or drainage coming from the ear
  • Dizziness or vertigo

Although OTC hearing aids do not require a prescription or medical exam, it may be beneficial for people to consult with a hearing health professional to be sure they are getting the most benefit from the device. Audiologists, like those at Mass Eye and Ear, can assess the fit of an OTC hearing aid and ensure its settings are adjusted appropriately to the user. They can also provide instruction on how to use and maintain the device.

It may also be helpful to meet with an audiologist before purchasing a hearing aid to review available options. For example, an audiologist at Mass Eye and Ear may conduct a Communications Needs Assessment to help determine whether prescription or OTC hearing aids are right for a patient, and even recommend specific OTC hearing aids if that is the case.

At Mass Eye and Ear, the costs of both prescription and OTC hearing aid services and the devices themselves are now charged separately in what is called unbundled pricing. Typically, audiologist services are “bundled” into the cost of the hearing aid, leading patients to pay for these services such as the communications assessment and device fitting whether they use them or not. This unbundled hearing aid model is designed to give patients more flexibility in how they pay for hearing aids and services, and to pay only for the services they want when they receive them.

Mass Eye and Ear currently offers one OTC hearing aid for purchase that they would recommend to patients, and the Audiology Department is always reviewing the market and will likely start selling other models as they become available.

What’s next for OTC hearing aids?

Photo of man using hearing aid

Going forward, Dr. Reed anticipates that the field of OTC hearing aids will continue to grow as the technology evolves, and as new and more innovative devices come onto the market. With accessibility and affordability as the overarching goals, this is great news for people with hearing loss.

“The hearing aid industry is relatively small,” said Dr. Reed. “With the FDA approval of OTC hearing devices, we expect that more options will become available in the future and that patients will benefit from the increased variety and lower prices that often come with a growing market.”

According to the National Council on Aging (NCOA), the average cost of OTC hearing aids is $1,600 per pair, but Dr. Reed often sees prices ranging from $800 to $1,000 per pair. That’s up to $4,000 less than prescription devices. And as the OTC hearing aid industry continues to grow, prices are expected to decrease even further.

Dr. Reed also hopes the increased availability and affordability of OTC hearing aids will have a trickle-down effect on medical insurance companies, encouraging increased coverage not only for hearing aids but also the associated services of audiologists and other hearing health professionals.

“Where affordability or accessibility are significant barriers to hearing intervention, over-the-counter hearing aids can be a great option for giving people with hearing loss the help they need,” said Dr. Reed. “We want to help as many people as possible hear as well as they possibly can.”

To schedule a Communications Needs Assessment or for help with fitting your over-the-counter hearing aids, call 617-573-3266 to make an appointment with an audiologist at Mass Eye and Ear.