You have probably seen in the news recently that hearing aids will finally be available over-the-counter (OTC) later this year. This change is follows enactment of the federal Over-the-Counter Hearing Aid Act in 2017. The law required the FDA to create a new category of hearing aids that allows consumers with perceived mild to moderate hearing loss to purchase hearing treatment without the intervention of a hearing professional (audiologist, hearing aid specialist, or ear-nose-throat doctor).
It took the FDA five years to finalize the new category and now that the category is defined and access to hearing loss treatment is about to expand, you may have questions about these products. Here are answers to some frequently asked questions that will help you better understand your hearing health and OTC hearing aids.
Research has shown the importance of hearing health and the impact that even minor hearing loss can have on our physical and mental well-being. Hearing loss has been linked to social isolation, depression, increased falls and balance issues, as well as cognitive decline. In fact, mild hearing loss doubles the risk of dementia, moderate loss triples the risk, and those with severe hearing impairment are five times more likely to develop dementia than their peers.1 As hearing loss increases, your brain starts to “forget” certain sounds that once were routine in your environment, such as the refrigerator running, a car approaching, or even certain people’s speech during phone calls. The more severe hearing loss becomes, the more sounds are excluded from your daily life. This can also increase your risk of social isolation and depression when it becomes too frustrating to connect with friends and family on the phone or in social settings.
The final rule was published in the Federal Register on August 17, 2022, and takes effect on October 17, 2022. OTC devices may be sold online, by mail, and in an array of brick-and-mortar locations, such as pharmacies, retail stores, and, perhaps, in hearing professionals’ offices.
The new OTC hearing aids devices are only intended for adults age 18 and older with perceived mild to moderate hearing loss. Most hearing losses occur gradually, and coping mechanisms are often use to reduce the impact of hearing loss on your daily life. It may be difficult to self-assess whether your hearing loss is mild, moderate, or more severe, especially if you have been living with it for some time. This is why it’s important to consult with a professional, as seen in the section below.
OTC hearing aids do not mandate the assistance of a hearing professional, however prescription hearing aid still require professional assistance for fitting and follow-up. That being said, hearing loss is a medical condition and hearing aids are medical devices. Determining the extent of your hearing loss and choosing a hearing aid is an important decision. We recommend seeking the advice and counsel of a licensed hearing professional.
Hearing loss can be caused by aging, extended exposure to loud noises, an underlying medical condition, medical treatment, or even earwax. The cause and type of each hearing loss is unique and seeing a licensed hearing professional, such as an ENT physician, audiologist, or hearing instrument specialist, can help you fully understand the nature of your hearing loss. These hearing professionals can also ensure your treatment provides customized sound quality that best benefits your unique hearing needs. And if you have moderately severe, severe, or profound hearing loss, you will still need to see a licensed hearing professional to obtain prescription hearing aids.
Because OTC hearing aids do not require the service of a hearing professional, it is expected that the overall price of the devices will be lower. Providing options at a wider range of price points will allow adults with mild to moderate hearing loss access a broader range of treatment options.
On average, prescription hearing aids purchased through a hearing professional range from $1,000 to $4,000. The total price includes the cost of the hearing aids (whether it be basic, mid-level, or advanced technology), the professional fitting, follow-up treatment, maintenance, troubleshooting visits, and sometimes batteries for the lifespan of the hearing aid(s).
Hearing professionals are available for consultations in most areas in the U.S. and welcome your questions about hearing health and hearing aids. You can find a list of local audiologists at the link below: https://www.hearing.org/find-a-hearing-professional/
The Hearing Industries Association is the trusted voice on hearing health care for product innovation, public policy, patient safety and education.
