Consumer alert: NYS DCP releases guidance for consumers purchasing newly approved over-the-counter hearing aids

Federal regulations now in effect allow consumers to buy hearing aids over the counter

By the New York Department of State’s Division of Consumer Protection 

For this week’s “Tuesday’s Tips,” the New York Department of State’s Division of Consumer Protection and Division of Licensing Services have released guidance to help consumers navigate the process of purchasing hearing aids. In 2022, new federal regulations went into effect allowing retailers to sell hearing aids over the counter. This means consumers with mild to moderate hearing loss can now buy hearing aids in store or online without needing a prescription or formal hearing test.

“As over-the-counter hearing aids become more readily available on store shelves, making them more affordable and accessible, it’s important for consumers to understand that shopping for these devices may not be as simple as it seems,” Secretary of State Robert J. Rodriguez said. “There are many factors to consider while choosing between over-the-counter and traditional prescription hearing aids, and I urge New Yorkers who are in the process of purchasing hearing aids to read our guidance to help decide which option can best serve their needs.”

New York State Office for the Aging Director Greg Olsen said, "Over-the-counter hearing aids are an option newly available for many consumers struggling with mild to moderate hearing loss. As with any major purchase – especially one that may be necessary to support quality of life – it's important to make an informed decision that suits your specific needs and expectations when it comes to fittings, maintenance and other factors. The state's Division of Consumer Protection has provided an exceptional resource to help, and I encourage all who are considering a hearing aid to read this new guidance." 

Professionally Fitted Hearing Aids vs Over-the-Counter Hearing Aids: What’s the Difference?

•Hearing test:

√ Over the counter: You will not receive a hearing test when you buy over-the-counter hearing aids.

√ Professionally fitted: A registered professional will test your hearing and help you pick a product that meets your needs. They will also refer you to a specialist if your hearing tests reveal a condition that is medically treatable.

•Choosing a hearing aid:

√ Over the counter: You will need to pick the product yourself and do your research to make sure the device you pick can meet your needs. Over-the counter hearing aids are generally the least-expensive option available. (Note: These hearing aids are intended for people with mild to moderate hearing loss and not severe hearing loss.)

√ Professionally fitted: A registered professional will discuss your specific hearing needs to help you pick a hearing aid that is most appropriate for you and your budget. A registered professional can help you find the right hearing aid for any level of hearing loss, including severe or profound hearing loss.

•Hearing aid fittings:

√ Over the counter: You are responsible for ensuring a proper fit and professional assistance is not provided.

√ Professionally fitted: A registered professional will program the device to your unique hearing needs. They will also make sure the device is comfortable and properly fits. The provider will work with you to make sure you are able to correctly use the device on your own.

•Returns and warranties:

√ Over the counter: Check the product return and refund policies before you buy. You may not be able to return or get a refund on an over-the-counter hearing aid purchase. Over-the-counter hearing aids are not required to provide a warranty.

√ Professionally fitted: A registered dispenser must allow you to return the device within 45 days and is required to issue you a refund.

•Follow-up visits and resolution of issues:

√ Over the counter: If you run into any issues with the hearing aids, you will need to contact the device manufacturer. There are no industry standards or laws requiring assistance be provided after you purchase over-the-counter hearing aids.

√ Professionally fitted: A registered professional will schedule follow-up visits as necessary to address any difficulties you may have with the device. They are also required to be available to provide adjustments and servicing for any hearing aids they have dispensed.

Routine Cleaning and Sound Quality Checks

√ Over the counter: You will not receive routine cleaning and sound quality check services when you purchase over-the-counter hearing aids.

√ Professionally fitted: If you purchase a hearing aid from a registered dispenser, you can take your device back to the dispenser for routine cleaning and maintenance for the best performance.

For more information, visit the Food and Drug Administration’s website.

About the New York State Division of Consumer Protection

The New York State Division of Consumer Protection provides resources and education materials to consumers, as well as voluntary mediation services between consumers and businesses. The consumer assistance helpline (1-800-697-1220) is available from 8:30 a.m. to 4:30 p.m. weekdays, excluding state holidays. Consumer complaints can be filed at any time at www.dos.ny.gov/consumer-protection. For other consumer protection tips and consumer alerts, consumers can follow the New York Department of State on Facebook, Twitter and Instagram, and check in every Tuesday for more practical tips that educate and empower consumers on a variety of topics. Sign up to receive consumer alerts directly to an email or phone here.