What are OTC (Over the Counter) Hearing Aids and Will They Change the Game?
Table of Contents
- A Little History
- Why Are Over The Counter Hearing Aids Now Possible?
- Are Over the Counter Hearing Aids A Good Thing?
A federal law was passed in 2017 directing the Food and Drug Administration to create a category of over-the-counter hearing aids for people with mild or moderate hearing loss, principally because only about one of four people who would benefit from a hearing aid purchase them. One big reason is cost, as a study we conducted earlier this year found.
The FDA missed its statutory deadline in August 2020 to create this category (the agency blamed the delay due to focus on COVID-19), although they do expect to issue guidance this fall. This article is intended to provide some history of hearing aid sales and technology and provide information on how they can benefit people with hearing loss.
A Little History
The sale of hearing improvement devices began in the mid 19th Century with ear trumpets and speaking tubes.1 These were advertised in the newspaper and sold by door-to-door salesmen.
Between the World Wars, the same carbon microphone technology that was bringing the radio into our living rooms was used to amplify sound and help hard of hearing people upgrade their ear trumpets. These were also sold by salesmen who might have been selling Fuller brushes the week before.
After World War II, a group of speech and hearing scientists in the army began researching and formulating a system to select hearing aids, prescribe setting and verify post-fitting benefit. This was the birth of the profession of audiology. In those early days, it was deemed a conflict of interest to both prescribe and sell the hearing aid, so the audiologist wrote a prescription that was filled by a new brick and mortar version of the salesman called a dispenser. After the fitting, the patient returned to the audiologist for verification. This consisted of an aided audiogram and word recognition testing, followed by several weeks of listening training called aural rehabilitation (AR).
In the 1970s, a series of working groups within the American Speech-Language-Hearing Association (ASHA) changed the acceptable practice from not selling hearing aids at all, to selling than at no profit. In 1978, the Supreme Court ruled that professional organizations could not prevent their members from competition. That year, ASHA changed its Code of Ethics to allow audiologists to sell hearing aids at a profit. 2 In retrospect, that was the point when my profession forever changed from a group of diagnostic and rehabilitation specialists to a group of salespeople with advanced college degrees.
In the late 1970s, the Food and Drug Administration (FDA) began regulating hearing aids as medical devices. These regulations included several rules that limited distribution to a very narrow sales channel (licensed hearing aid specialists or audiologists) 3. FDA’s website acknowledges that this sales channel restriction might be part of the reason that more people don’t get hearing aids when then need them.
I started my undergraduate studies in speech and hearing in 1986. Very early in my coursework, the system for buying hearing aids only from a licensed audiologist or dispenser was framed as “protecting the consumer.” This concept is justified with language that provides anti-fraud and buyer’s remorse protection. What they don’t talk too much about is whether the device itself might be dangerous. As hearing aids became miniature computers in the digital age of the late 1990s, it occurred to me that the fact that a computer has replaced my old mini screwdriver in setting the device, significantly reduced how potentially “dangerous” the device itself could be. In the analog days, I could accidentally set the power of a hearing aid too high and cause discomfort or even damage hearing. In the digital age, the computer software written by the manufacturer (called fitting software) sets absolute limits of performance, much like how a high-performance sports car or motorcycle can be electronically throttled to be legal for street use. This creates a fail-safe that makes the hearing aid itself much more inert. Looking back, it seems that once this was the norm, hearing aids should have been re-classified as consumer electronics with regulations for the software to limit output.
In 2013, I taught a weekend intensive on hearing assistive technology for a group of hard of hearing “super users” and community leaders. The Consumer Electronics Association Foundation sponsored the course. The Foundation representative was from Samsung. When I walked him through the workflow of one of the Big 6 fitting software modules, I could see the wheels turning. We discussed the “consumer protection” angle, and I pointed out several places in the workflow where I (as the professional) could opt to override the FDA “red flags” with a patient waiver. He asked how important those flags were. When I suggested that they were indeed essential, he and I had a very enlightening conversation about how software could provide bullet-proof adherence to these guidelines. This conversation fundamentally changed how I looked at the potential for companies who were good at software-driven audio to help both my patients and the 80+% of their brethren who were suffering without help.
After years of looking at market penetration for hearing aids stagnant at 25 percent, I am convinced that it is the FDA classification and its protection of the sales channel that keeps four of every five hard of hearing people from getting the help they need.
Why Are Over The Counter Hearing Aids Now Possible?
After many years and a lot of research reframing hearing loss as a public health issue rather than an individual medical problem 4, groups like AARP and the Hearing Loss Association of America (HLAA) worked with lawmakers. They moved the mountain that is the FDA. More accurately, they revealed that the long-standing assertion by audiologists and hearing aid specialists that “only they” could fit hearing aids safely was not supported by data compared to the public good for creating alternative sales channels for devices that improved hearing, communication and health-related quality of life.5
On August 18, 2017, the FDA Reauthorization Act of 2017 directed the FDA to create a category of OTC hearing aids for adults who might have mild-to-moderate hearing loss. As part of this process, the FDA must issue a proposed rule by August 18, 2020, and a final rule within six months of the close of the comment period on the proposed rule. 6
As of August 11, 2020, there is no indication of the FDA website if this deadline will be pushed due to the disruption of COVID-19. I would not be surprised to see a delay since hearing aids, while important, are certainly not top of mind during a pandemic. What we already know about OTC hearing aids is that they will be restricted to people with presumed mild to moderate hearing loss who are over the age of 18. To date, there are not any products officially listed as OTC hearing aids, but the big players in consumer electronics have clearly been ramping up for the last three years. In 2019, Apple added features to its AirPod Pro product that, in conjunction with an iOS update, would allow an iPhone to function as a hearing aid. 7. Bose modified a Bluetooth headset to amplify ambient sounds8. Several companies make electronic hearing protection for hunters and sport shooters that, in addition to shutting down when a shot is fired, make it easier to hear game and those near you at the range.9, 10 These are not OTC hearing aids on the books, but they indeed enhance hearing and are sold outside the hearing aid sales channel.
Are Over the Counter Hearing Aids A Good Thing?
Does this shift in focus mean that I and other audiologists need to look for a new profession? Some in my field are worried, but as a person with more hard of hearing friends and family than not, I’m quite encouraged. I’ve been a technology geek and early adopter since middle school. When I look at the biggest hurdles to communication for my hard of hearing “peeps,” I see that while the Big 6 have done an excellent job, their solutions are limited to their “stuff on the or in the ear” lens. If we zoom out a bit, the problems of distance, reverberation, and background noise also affect those making videos for social media. Influencers who capture their lives not only in the studio but also in the real world have sparked a vast competition for high quality, small, low-cost wireless microphones. While these currently can’t talk to hearing aids and cochlear implants, that limitation is self-imposed by the hearing aid and cochlear implant manufacturers. The radio technology is usually the same (Bluetooth LE or 2.4 GHz). If smartphones behave like hearing aids under the OTC umbrella, these consumer electronic devices can make your grandkids’ “unboxing” videos sound great, and allow you to hear at dinner when restaurants re-open post-COVID.
The other thing that I like about the OTC classification is that even before the pandemic, I and many people in my cohort (mid ’50s, tech-savvy) preferred buying our electronics online. We also like the ability to configure and customize our solutions. Finally, opening up a hearing enhancement to the consumer electronics industry brings an exponentially larger hive-mind to addressing the problems that the tiny hearing aid industry has struggled to conquer. This isolation of technology and thinking has relegated hard of hearing people to accepting what is offered rather than what is possible.
I’ll keep my eye on the FDA process and will provide my opinion on the initial rulings and then loop back when things finalize.
As Bob Dylan said, the times, they are a changin’, and I, for one, think it’s going to be nothing but positive for people with hearing loss.