On Monday, consumers can buy hearing aids without a prescription, possibly saving thousands of dollars per pair.
The new devices — designed for those with mild to moderate hearing loss — are expected to transform the hearing aid market. They are being sold at stores and online without a medical exam, prescription or special fitting by an audiologist. This follows a ruling on Aug. 16, when the Food and Drug Administration (FDA) agreed to allow over-the-counter hearing aids to be sold directly to consumers.
Although the first models are expected to largely resemble the devices you can get through a hearing professional, there are some important differences.
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Here are five ways over-the-counter devices differ from prescription versions.
1. Over-the-counter (OTC) hearing aids are for mild to moderate hearing loss only, while prescription hearing aids can help with all types of hearing loss.
- Over-the-counter hearing aids: They are intended for adults with perceived mild to moderate hearing loss, the FDA says. That means your hearing loss range is between 20 and 60 decibels (dB). And you don’t need a hearing test to try out an over-the-counter device, the FDA says. Signs that you may have mild to moderate hearing loss include: You often ask people to repeat themselves or speak up, speech sounds muffled, you have trouble hearing in noisy places or you turn up the volume on the TV higher than other people prefer.
Authors Frank Lin and Nicholas Reed at the Johns Hopkins School of Medicine lay out the steps to hearing health, including new advice on just-released over-the-counter hearing aids.
- Prescription hearing aids: If you have severe hearing loss, you need prescription devices. You may have severe hearing loss if you have difficulty hearing in a quiet place and trouble hearing loud sounds, such as a truck driving by. Some experts say prescription devices are also a better choice for those with hearing loss in only one ear, those whose hearing loss was caused by excessive noise damage or those whose hearing loss was caused by chemotherapy or another drug, since those conditions can be difficult to treat.
However, anyone with any level of hearing loss can benefit from prescription hearing aids. Although they are more expensive, prescription devices offer the most sophisticated technology and will be better able to treat the nuances of different types of hearing loss. They also include built-in help from a hearing professional to fit and adjust them, so they are a good choice for someone who has tried an over-the-counter option without success.
2. Prescription hearing aids are ordered from a hearing specialist or audiologist, but OTC hearing aids will be available in stores, pharmacies and online without a fitting or exam.
- Over-the-counter hearing aids: You will now be able to buy them in pharmacies, stores and online without a medical exam or a special fitting from an audiologist. Retailers including Best Buy, Walgreens and CVS plan to carry the hearing aids in their stores and online. All over-the-counter hearing aids will need to meet FDA quality standards.
- Prescription hearing aids: They are ordered by an audiologist or a hearing instrument specialist who has tested your hearing using advanced diagnostic tools. The hearing professional will help you fit and adjust your new hearing aids at a follow-up appointment once the devices come in.
3. OTC hearing aids are expected to cost substantially less than prescription hearing aids.
- Over-the-counter hearing aids: The average price of over-the-counter devices remains to be seen, but they are expected to offer substantial savings compared with prescription versions. Government officials estimate Americans will save on average $2,800 a pair. Most private insurers and Medicare don’t cover the devices.
- Prescription hearing aids: They cost on average about $4,600 per pair, though premium models are priced as high as $12,000. The total price covers the cost of the devices, the professional fitting and follow-up treatment, as well as maintenance and troubleshooting visits for the life of the device.
4. Prescription hearing aids require the help of a health professional for adjustment, while OTC hearing aids can be adjusted by the user.
- Over-the-counter hearing aids: You will configure them yourself, most likely using software or a smartphone app. Unlike getting a new pair of glasses that correct your vision as soon as you put them on, hearing aids can take some time to get used to, so it may take a few weeks and several adjustments before you are satisfied.
If you are still having trouble hearing after using the built-in device settings, you may want to look for an audiologist willing to help with fitting over-the-counter hearing aids. Barbara Kelley, executive director of the Hearing Loss Association of America, predicts more audiologists will offer that service as over-the-counter options become available.
- Prescription hearing aids: A hearing health professional will program your hearing aids to make sure they fit comfortably in your ears and provide the maximum benefit. He or she will also help you practice putting them in and taking them out and show you how to adjust the settings for different environments. You will have regular follow-up appointments for fine-tuning and maintenance, and you can go back at no additional charge anytime you have a problem for the life of the device.
5. OTC hearing aids may eventually have new designs and look different from prescription hearing aids.
- Over-the-counter hearing aids: At first, OTC devices may largely resemble the simplest prescription hearing aids. But experts say allowing manufacturers to market directly to consumers will foster competition and spur innovation in hearing aid design.
Nicholas Reed, an audiologist at Johns Hopkins University Bloomberg School of Public Health and co-author of the AARP’s new Hearing Loss for Dummies, predicts that allowing over-the-counter devices will prompt “some crazy technology changes” related to what a hearing aid looks like in the next 10 or 20 years.
- Prescription hearing aids: If you get a prescription pair, you will have a range of options when it comes to design, including behind-the-ear, in-the-ear and discreet custom styles. With the help of an audiologist, you will be able to try out different designs for comfort and fit.
Michelle Crouch is a contributing writer who has covered health and personal finance for some of the nation’s top consumer publications. Her work has appeared in Reader’s Digest, Real Simple, Prevention, The Washington Post and The New York Times.
Editor's note: This story, originally published Sept. 1, 2022, has been updated to include new information.