Is the FDA’s OTC Hearing Aid Rule Already Obsolete?

Some thoughts on World Hearing Day

Though discussions have been going on for a very long time, the first concrete action took place when the FDA Reauthorization Act of 2017 (FDARA) mandated the creation of an OTC hearing aid category. Five years will have passed before the OTC rule takes effect later this year. That is an eternity in consumer tech. We have already moved beyond the devices envisioned when OTC was first proposed. The coming ability to load hearing software from a third party into unregulated consumer devices after purchase threatens to render the OTC regulations obsolete even as they are finalized.

The hearables revolution

Nowhere is the speed of consumer electronics development more apparent than with true wireless stereo (TWS) earphones, often called “hearables.” Until recently, headphones for music listening have been functionally and physically distinct from hearing aids, whose primary purpose is to selectively amplify live speech. But TWS hearables are different because they can be worn wirelessly in a person's ears just like hearing aids, and they have been gaining increasing intelligence with startling speed. This puts unregulated hearables on a collision course with the OTC hearing aid rule.

The sheer popularity of consumer hearables will force the pace of change. Consider that while roughly 20 million hearing aids will be sold in 2022, consumers will buy over 300 million consumer hearables, according to industry consultant Nick Hunn. That’s upwards of 15 times more earbuds than hearing aids shipped. “The consumer electronics industry dwarfs the hearing industry” observed Karl Strom after his visit to the Consumer Electronics Show, adding that “wireless earbuds, and the innovative technologies related to them, were widespread at CES 2022.”

Increasingly, consumer electronics companies have turned their attention to hearing issues. This can only be a good thing as companies like Apple have far greater influence over consumer behavior than hearing aid companies do. For example the popular Apple Watch can warn users when the environmental noise level is reaching unsafe levels, and AirPods Pro offers built-in hearing enhancement features. As Nancy M. Williams concludes in Auditory Insight’s Q2 2021 research note, “By creating dialogue on noise levels, Apple is nudging consumers to consider their hearing health far more often and comprehensively than ever before.”

Entering through the back door

In addition to having the potential to change attitudes about hearing, consumer brands like Apple are driving device innovation at a rapid pace.?An increasingly popular feature in modern TWS hearables is hearing personalization. Its function is similar to self-fitting hearing aids in that the user takes a hearing test to create a personalized profile. However, this profile is applied to streaming audio, not the microphones used for amplifying speech. A number of popular earphone brands have included hearing personalization including Skullcandy, Apple, Jabra, Anker / Soundcore and others, with more expected. As most people experience hearing degradation with age, hearing personalization can provide a broad swath of the population with an enhanced listening experience. Because age-related hearing loss generally begins in the high treble, noticeable degradation of music quality can occur considerably sooner than for speech. Herein lies the “back door” to hearing loss awareness.

Normally people do not perceive they have hearing loss until they struggle to understand others speaking. Even then, years can pass before a person who recognizes the onset of hearing loss seeks treatment. But someone who buys an earphone with hearing personalization, runs the test, sees their hearing profile, and perceives improved music quality as a result has now been introduced to hearing treatment in a completely non-threatening way. This has the potential to revolutionize how people think about hearing and reduce the time before they seek care. The same is true for models that provide "restaurant mode" noise filtering to hear others better in loud environments.

The possibilities are limitless

No discussion about the convergence of hearing aids and consumer hearables would be complete without acknowledging that there are effectively no limits placed on headphone output. There are even websites devoted to helping people find the loudest headphones. On the other hand, the proposed OTC hearing aid rule caps output on OSPL90 basis at 115db, or 120db with input-controlled compression. As Bose pointed out in their comments to the proposed rule, Appendix A, an OSPL90 of 120db equates to about 105db for music, a figure readily obtainable in headphones sold today. While it is only rarely that the listening environment would cause OTC hearing aids to reach the limit, consumers can stream music through earphones at 105db for hours every day if they wish, unsafe as that is.

Perhaps more important to this discussion is that while some advocate for a gain limit on OTC hearing aids, there are no limits to the gain that may be applied for hearing personalization of streaming music. A TWS hearable device that performs a hearing test and applies a correction algorithm to streaming music at any level is still just an unregulated consumer product. But include correction to the microphones for live speech and it becomes a regulated hearing aid. As long as the hearing correction function is integral to the device hardware, this regulatory disparity will hold up. But what happens when that is no longer the case?

The "app store" model is coming to hearables

Today both hearable devices and hearing aids have their functionality baked-in to the hardware. As long as hearing software must be incorporated into a device at the factory, regulations are easy to define and enforce. But the time is rapidly approaching when a consumer will be able to buy an unregulated hearable device and load a hearing app after purchase in the same way they do with mobile phone apps. Imagine hearing software sold online for either a fixed price or on subscription basis. One might try a free version for 30 days and move on to another if not satisfied. Some apps might employ machine learning techniques to extract speech from noise. Others might combine personalized amplification and directional mics. The consumer will have a range of options to shop, try, and buy, effectively bypassing today’s hardware-focused OTC rule and all its technical limits.

With the rapidly expanding capability of processor chips used in hearables, the availability of programmable devices, with an app selection to match, is not far off. Already hearable pioneer Bragi (who began using the term "ear computer" in 2014) describes that through their operating system, makers of hearables can “sell a continuously growing pool of new Apps, Services and product improvements through Over-the-Air updates.” Change is coming.

Once more unto the breach

When in 2015 the President's Council of Advisors on Science and Technology (PCAST) recommended that an OTC hearing aid category be created, it added that PSAPS should be allowed “to make truthful claims about capabilities like improving hearing…” This in tacit recognition that useful devices were already becoming available, getting favorable press, and threatening to undermine the existing hearing aid regulations.

Seven years later, those who worked to bring OTC hearing aids to life may be breathing a sigh of relief that the contest is nearly finished. But unlike the PCAST recommendation, the current rule doesn’t even consider the capabilities of hearable devices now on the horizon. It’s time to start the game anew, before the current regulations are once again overtaken by technological advances.