It has been a long time coming, but it’s finally 2022, and the greatly anticipated over-the-counter hearing aids are expected to hit the market this year. OTC hearing aids are those that can be purchased without a prescription from a licensed audiologist, similar to how people purchase reading glasses from a drug store.

Traditional prescription hearing aids can cost thousands of dollars, and many people have never been able to afford a prescription as the upfront cost of an audiologist appointment can be prohibitive. This change will bring new players to the forefront of the hearing aid industry, ultimately driving new innovation and competitive pricing that greatly benefits consumers.

This is a huge development for the hearing aid industry, as it will make hearing aids more accessible and affordable for millions of people with mild to moderate hearing loss. But with the first half of 2022 nearly behind us, over-the-counter hearing aids still remain elusive. So, what’s the hold-up? Can consumers still expect to see OTC hearing aids on shelves before the end of this year?

First, How Did We Get Here?

For decades, the FDA has regulated hearing aids as prescription medical devices.  It has meant that hearing aids are more costly and inconvenient for people suffering from hearing loss to get them.

The FDA Reauthorization Act of 2017 was the first legislation to state that the FDA “must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids.” This was a revered change to FDA regulations that would have a lasting impact for those with mild to moderate hearing loss. Unfortunately, this legislation was followed by four years of inaction.

It wasn’t until July 2021, when President Biden’s executive order “Promoting Competition in the American Economy” identified hearing aids as an area where American families are paying overly high prices for necessities. The order called on the FDA and tasked them with issuing guidance and regulations for OTC hearing aids within 120 days.

Why Are OTC Hearing Aids Still Unavailable?

The FDA has been clear that they want to make sure over-the-counter hearing aids are both safe and effective before making them available to consumers. In order to get approval, manufacturers must submit data from clinical trials proving that their products meet their standards. While some manufacturers have already submitted their data, the FDA is still in the process of reviewing it.

With any new product, there is always a risk that something could go wrong. And when it comes to hearing aids, there is additional concern as they will be used on people’s ears — a sensitive part of the body. That’s why the FDA wants to make sure that OTC hearing aids are as safe as possible before approving them for public use.

In addition to standards and regulations for the product, there is also product messaging to be considered. The FDA has to review and evaluate proposed labeling requirements for OTC hearing aids from groups lobbying in support of hearing loss consumers. The AARP, for one, is advocating that there should be a 60-day return policy, while ASHA (American Speech-Language-Hearing Association) is requesting that labels acknowledge the value of seeing a hearing health professional before using a hearing aid.

While unfortunately, it took a long time to see any action towards new OTC regulations, the FDA is at least determined (rightfully) not to rush the process at the sacrifice of quality control, despite the less-than favorable wait time.

What Are Other Alternatives to Prescription Hearing Aids?

People with mild to moderate hearing loss can still find relief with some of the other products on the market. Direct-to-consumer hearing aids are a suitable option and are easily accessible online.

As you wait patiently for over-the-counter hearing aids, get to know some of the new products that online retailers like Lexie Hearing are eager to make available over the counter. Be sure to stay up-to-date on the latest FDA news and as soon as a decision is made, we will be sure to let you know.