Soon hearing aids will be sold without a prescription, but could the rules already be outdated?


The hearing aid market is in a state of flux as new legislation on the horizon will allow people to purchase over-the-counter devices that can help them hear more clearly if they have mild to moderate hearing loss. Here, hearing aid industry insider Andrew Bellavia of Knowles Corp. warns that OTC (Over the Counter) hearing aid legislation may soon be outdated.

Discussions to legalize OTC (Over the Counter) hearing aids in the United States have been ongoing for a long time. Finally, concrete actions took place when the FDA Reauthorization Act of 2017 (FDARA) mandated the creation of a new category of over-the-counter hearing aids.

Almost five years have passed and the OTC rule will come into effect later this year. In terms of consumer technology, five years is a very long time. Since the legislation was passed, the technology has outgrown the type of devices envisioned when the category was first proposed. For example, it will soon be possible to load third-party hearing software onto unregulated consumer devices, which threatens to render OTC regulations obsolete before they are finalized.

Nowhere is the speed of development in consumer electronics more apparent than in the market for true wireless stereo (TWS) headphones. These devices are often referred to as “hearables” and bear little resemblance to traditional wired headphones, even though they share the same primary function of playing music. Hearing aids, on the other hand, are primarily intended to selectively amplify live speech. But TWS hearing aids can be worn wirelessly in a person’s ears, just like hearing aids. In addition, they are increasingly intelligent and have surprising processing speeds. This puts unregulated hearing aids on a collision course with the new OTC hearing aid rule.

The popularity of consumer hearing aids and their improved sound quality will also lead to changes in hearing aids. In 2022, hearing aid sales will reach approximately 20 million units. Meanwhile, consumers will buy more than 300 million consumer hearing aids like TWS headphones. This figure, according to industry consultant Nick Hunn, is up to 15 times greater than the number of hearing aids shipped.

Increasingly, consumer electronics companies are turning their attention to hearing issues. This can only be a good thing because companies like Apple have far more influence on consumer behavior than hearing aid companies. For example, the Apple Watch can warn users when ambient noise levels reach dangerous levels, while the AirPods Pro offer built-in hearing enhancement features. As Nancy M. Williams concludes in Auditory Insight’s Q2 2021 Research Note“By creating a dialogue about noise levels, Apple is urging consumers to consider their hearing health far more often and more comprehensively than ever before.”

Besides potentially changing attitudes towards hearing, consumer brands like Apple are driving innovation at a rapid pace. An increasingly popular feature in modern TWS hearing aids is hearing customization. Its function is similar to self-adjusting hearing aids in that the user takes a hearing test to create a personalized profile. However, this profile is applied to streaming audio rather than microphones used to amplify speech. Popular earphone brands with hearing customization include Skullcandy, Apple, Jabra, Anker/Soundcore and others, and many more are expected.

Since most people experience hearing loss with age, personalizing hearing can provide an improved listening experience. Because age-related hearing loss typically begins in the treble high range, noticeable degradation in music quality can occur considerably earlier than for speech. This is where the “back door” to hearing loss awareness lies.

Normally, people don’t notice they have hearing loss until they have trouble understanding someone else who is speaking. Even then, years can pass before getting treatment. But someone who buys an earphone with hearing customization and takes the test, will see their hearing profile and perceive an improvement in music quality. This is a totally non-threatening way to introduce them to auditory processing. It has the potential to revolutionize the way people think about hearing and reduce the time it takes for them to seek treatment. The same goes for models that offer a “restaurant mode” that filters out noise so they can hear others better in noisy environments.

No discussion of the convergence of hearing aids and consumer hearing aids would be complete without acknowledging that there are effectively no limits imposed on headphone output. There are even websites aimed at helping people find loudest headphones. On the other hand, the proposed rule for OTC hearing aids limits production. While it’s rare for a listening environment to cause OTC hearing aids to reach their output limit, consumers can stream music through headphones at 105 dB for hours every day if they choose. , which could damage your hearing.

While some in the industry advocate a gain limit on OTC hearing aids, there are no limits to the gain that can be applied for music aural customization. A TWS hearing aid that performs a hearing test and applies a correction algorithm to music at any level is still an unregulated consumer product. But if the correction is applied to the microphones for live speech, then the device becomes a regulated hearing aid. If the hearing aid function is an integral part of the device hardware, this regulatory disparity will continue. But what happens when this is no longer the case?

Today, hearing aids and hearing aids have their functionality built into the hardware. If hearing software needs to be built into a device at the factory, the regulations are easy to define and enforce. But the time is coming when a consumer can purchase an unregulated hearing aid and load a hearing app after purchase, just like a mobile phone app.

Imagine hearing software sold online for a fixed price or on a subscription basis. Users could try a free version for 30 days and switch to another if they were not satisfied. Some applications may use machine learning to extract speech from noise. Others may combine custom amplification and directional microphones. The consumer will have a range of options to buy, try and purchase, effectively circumventing the current hardware-driven OTC rule with all its technical limitations.

With the rapidly expanding capacity of processor chips used in hearing aids, the availability of programmable devices with apps cannot be far off. Already audible pioneer Bragi (who started using the term “earpiece” in 2014) describe that through their operating system, hearing aid manufacturers can “sell an ever-growing pool of new apps, services, and product enhancements through over-the-air updates.” Change is coming.

All those people who worked hard to bring OTC hearing aids to life may be breathing a sigh of relief that their battle is coming to an end. However, the new legislation does not take into account the capabilities of hearing aids on the horizon. It’s time to start all over again before current regulations are overtaken by technological advances.


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