New FDA rules on hearing aids could flood the market with products


The Food and Drug Administration (FDA) has created a new “over the counter” (OTC) category for hearing aids. It allows adults with mild to moderate hearing loss to purchase hearing aids from general retailers and online. In the past, these devices were strictly controlled and required a visit to an audiologist.

Removing some of the old regulations aims to increase access to hearing health by removing barriers and reducing costs within the hearing aid industry. It should also encourage a number of new entrants, which could significantly increase choice. So what does the new normal for hearing aids look like?

Over-the-counter hearing aids are the new normal

Two types of air conduction hearing aids that will now be considered OTC hearing aids by the FDA. Sandra Stafford / Digital Trends

For starters, most hearing aids will fall into the new OTC category. This means that adults will be able to buy them at any store, pharmacy, online store or any other place that sells them. The regulations do not even require age verification. The OTC category will cover a variety of hearing aid designs, including all air conduction models within certain technical specifications. Most importantly, they won’t require a visit to an audiologist. If you think you could benefit from a hearing aid, you can choose from a variety of self-assessment tests to determine what you need.

Air conduction hearing aids are currently the most common type of hearing aid. When you think of a hearing aid, you probably imagine an air conduction model. They use small microphones to pick up sound, an amplifier to tune the sound, and a receiver (or speaker) to transmit the sound into your ear. Over-the-counter hearing aids will have limitations in their ability to amplify sound.

These limits will still provide enough amplification to treat mild to moderate hearing loss, without being so loud that it could actually harm someone’s hearing. They are intended for people with perceived mild to moderate hearing loss. But let’s talk about “perceived”.

Self-assessment is unreliable

The self-assessment will be incredibly convenient, especially for people who live considerable distances from their nearest audiologist. But there are reasons to be skeptical about the extent to which people can self-report their own hearing loss. Studies suggest that we are not a reliable source on the matter. Personally, I told my doctor that my hearing was normal just before finding out that I had “moderately severe hearing loss”.

People generally cannot gauge their degree of hearing loss, and they are no better at assessing the cause. The problems that cause hearing loss vary in severity, from excessive earwax to benign tumors. Trying to fix these issues with over-the-counter hearing aids won’t solve anything, and even worse, it will likely delay treatment. The FDA considers these risks sufficiently low and rare to be borne by the consumer.

The costs of a bad fit

Bose SoundControl hearing aids

There will also be an associated cost. Even established hearing aid brands can have return or comfort issues, and customers have relied on good return policies to try multiple hearing aids until one fits their needs. Eargo, a popular hearing aid company, had a return rate of just over 24% in 2021. Hearing aids have traditionally had lengthy return policies and warranties, but the FDA does not require them for hearing aids. over-the-counter hearing aids.

The move towards self-assessment shifts all that work and cost onto the consumer. You should assess your own hearing loss from multiple sources, compare products and return policies, install the devices yourself, follow up with customer service audiologists, and then return the devices when they sound twangy or you ears itch. You can try another over-the-counter hearing aid – if the process hasn’t completely disabled you from the hearing aids.

Personally, I suggest at least calling an audiologist. Audiometry exams can be surprisingly affordable, and at least you’ll know what kind of hearing loss you have.

Audiologists can help you

If they don’t visit audiologists in their practice, hearing aid users will still see a lot of them. OTC hearing aids with generous return policies keep plenty of audiologists on staff ready to answer any questions. I received emails from the Eargo customer service audiologist almost daily, and she was very helpful.

In other words, audiologists can fill the gaps in the app-based hearing tests and hearing test kiosks that are about to pop up everywhere, telling us how common hearing loss is and urging us to check it out. our hearing. And for anyone without clinical hearing loss, there are wearable speech-enhancing devices.

Speech-enhancing hearing aids?

Jabra Enhance Plus headphones are tiny.
Sandra Stafford / Digital Trends

Now that the FDA has loosened up the regulations, you can expect the whole concept of what is – and isn’t – a hearing aid to get a little fuzzier. You’ll start to see more and more of the companies you already know in the world of headphones and earbuds start making inroads under the banner of “speech-enhanced hearing aids”, a product category that uses the hearing aid technology, but is marketed to help people with no hearing problems.

The first out of the door will be the big hearing aid companies that also own audio brands. Jabra-owned GN Store Nord has already started selling the Jabra Enhance Plus, and you can be sure Sonova-owned Sennheiser won’t be far behind. Promising “enhanced conversations,” these products don’t appear to be exclusively healthcare devices. And what about Apple? Don’t be surprised if the next AirPods feature an even better version of the existing Conversation Boost mode.

Hearing health

Despite all the potential of these new markets, it is likely to remain mostly potential. Ownership and use of hearing aids is consistently low. The list of reasons includes poor benefits, background noise, uncomfortable fit, and negative side effects. Cost is a factor because if you can’t afford a hearing aid, it doesn’t matter how well it fits. On the other hand, if everyone seems to be talking to you through a tin can phone, it doesn’t matter how affordable your hearing aid was – it will always stay in its box.

Now that they’ve fought their way into the hearing aid market, we should expect these consumer hearing companies to offer a long list of benefits, without embarrassment. If they don’t, we can easily eliminate them.

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