Hearing Aids Over the Counter - Are They Safe?

The FDA recently approved hearing aids over the counter at pharmacies, big box stores and some audiology offices. These devices are intended for people with mild-to-moderate hearing loss.

The over-the-counter models are available online and at select CVS, Walmart and Best Buy locations starting this week. The devices include presets that are designed to fit different levels of hearing loss. 

Cost

While traditional fee-for-service Medicare and many health insurance policies don’t cover hearing aids, new federal rules allow consumers to buy them over the counter starting this fall. Consumer advocates are welcoming the development, which should lower prices and encourage more people to address their hearing loss.

But it’s important to think about the costs associated with OTC devices. In addition to the price of a pair of devices, there may be additional fees that you should consider. For example, most prescription hearing aids include a visit with an audiologist or otolaryngologist, who test your ears and evaluate your needs to help you select the right device. These providers also help you get used to wearing them and provide services like cleaning and adjustment. When purchasing OTC aids, you may need to pay for these a la carte services, such as a warranty or service plan, separately.

Another cost to consider is the availability of virtual customer support for OTC devices. Many companies that make OTC aids offer robust manuals and online videos for setting up and troubleshooting the devices. Some also have phone-based customer support specialists. However, these specialists won’t be able to hold your hand or show you how the products work in person.

Finally, there’s the question of whether OTC hearing aids will be affordable for people with mild to moderate hearing loss. People with more severe losses might still want to consult an audiologist or otolaryngologist before buying over-the-counter aids, particularly if they have difficulty hearing in loud environments. For example, if you have to ask people to speak more clearly or repeat themselves, turn up the volume on your television or radio, or find yourself turning up the music too high, these are signs of severe hearing loss and may not be corrected by OTC aids.

Technology

Many people who suffer from hearing loss avoid getting help because they cannot afford prescription aids or don’t feel comfortable wearing them. A new type of OTC device may help some overcome these obstacles.

OTC hearing aids are regulated by the FDA and can be purchased at drug stores, big box retailers, online, and tech shops. They are typically available in two categories: legacy (traditional) or wireless devices that look like earbuds and include basic features such as volume control, and self-fitting models that can offer greater customization through technology such as hearing tests, software, or smartphone apps.

These technologies can also improve comfort, including noise cancellation and better speech in noisy environments. They may also allow for better connectivity to other devices, such as televisions, computers, and mobile phones. They are typically easy to use and require little or no face-to-face guidance from a healthcare professional.

However, a person who needs a high level of functionality should still seek a consultation with an audiologist. These professionals are trained to diagnose hearing problems and configure devices based on the person’s specific needs. They are also able to evaluate whether an OTC device will provide the results a patient wants.

In addition, if you believe a company or individual is marketing a medical device that violates FDA regulations, you can report it. The FDA offers instructions and an online form for this purpose. This is important because it helps the agency become aware of issues that it might not otherwise learn about. It can then take further action or correct any potential violations. This information can be found at Reporting Allegations of Regulatory Misconduct.

Customization

Right now, people who need hearing aids must visit a doctor or audiologist to undergo a comprehensive hearing evaluation and receive a prescription for a custom-fitted device. But soon, some people with mild-to moderate hearing loss will have a less expensive option. The FDA has approved new rules that allow some types of over-the-counter hearing aids.

In some cases, the new devices are self-fitting and allow users to adjust their settings. Others, such as those offered by a direct-to-consumer company called Eargo, come with an app that allows users to customize the device beyond its out-of-the-box settings. These apps also include a hearing test that helps the user determine what sounds better for them.

The benefits of over-the-counter devices include lower prices and more convenience, but there are some downsides. For example, the lack of a face-to-face appointment might seem convenient at first, but it can be challenging to manage the technology without the guidance of an audiologist. Audiologists are usually trained to assist their patients with the process of getting accustomed to hearing aids, and many patients find comfort in the support they receive from an audiologist.

Some experts say that the new over-the-counter hearing aids may not be as effective as prescription models, but they might be an excellent option for some people who have mild to moderate hearing loss. They are especially suitable for those who do not have a lot of money to spend and who live in areas where there are few audiologists or hearing healthcare professionals. Some of these devices also come with a trial period, which can be beneficial for people who are not sure whether they will work for them.

Convenience

A new set of rules from the FDA is allowing manufacturers to sell hearing aids without a prescription. This could make them more affordable, but is it safe? We talked to experts to get their take on the pros and cons.

The biggest drawback of OTC hearing aids is that they don’t come with a professional fitting or diagnosis, which can be a huge barrier for those who need help. While some OTC models have apps that let you adjust your devices from your phone, most of them require a visit to a retail store to pick out a model and get it set up. Some companies offer expert customer support, but it’s important to find out how available it is and what kind of expertise the representatives have.

Another potential problem is that OTC hearing aids may not perform as well as prescription models. Many have a limited range of preset programs that are intended for adults with perceived mild to moderate hearing loss. They may not be able to help people with severe hearing loss, and they may not filter out background noises or increase the volume on specific sounds like dogs barking or children crying.

Despite these concerns, the availability of OTC hearing aids could be a big step forward for tens of millions of people who have untreated hearing loss. Some of these people are reluctant to reveal their hearing difficulties and would rather just live with the problems, but if they find that OTC devices work for them, they might be motivated to seek out an audiologist or licensed hearing aid dispenser for more personalized help. In fact, a study recently showed that those who see an audiologist get better results with their hearing aids than those who buy OTC devices.

Warranty

The FDA's regulations do not require OTC hearing aids to come with a warranty. But many manufacturers do offer a trial period and robust customer support. Some companies also provide manuals and online videos to help you get started using your device.

A trial period allows you to test your new hearing aids in different environments to see if they work well for you. Some retailers like CVS and Walmart allow you to purchase a pair of hearing aids online and in store, while others offer online and phone support. Some companies, like iHEAR, even have an app that can administer a basic hearing test and adjust the settings of your hearing aids.

Most OTC devices are designed to address mild to moderate hearing loss. If you have severe or profound hearing loss, you should consult a doctor or audiologist for a professional recommendation.

While working with a professional audiologist has its advantages, many people are looking for alternatives. It may be easier and more convenient to buy a hearing aid over the counter, especially if you have issues with transportation or live in a rural area.

However, it is important to research the available options and choose the best device for you. Some OTC devices are not as effective as prescription models, and some may not fit comfortably in your ears. Some also have lower levels of customization. You should also consider the return and warranty policy. Some retailers, such as Hy-Vee and iHEAR, have good reputations in the marketplace. However, some have mediocre reviews on TrustPilot and other websites. Whether you go with an online retailer or a traditional retail outlet, you should find out what support options are available to you and how long the warranty lasts before making your decision.

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