Over-The-Counter (OTC) hearing aids are now available

Some form of hearing loss affects many over the age of 60 (NYTimes): "mild to moderate hearing loss ... affects about one-quarter of people in their 60s, half of those in their 70s and three-quarters of those over 80.” To a hearing impaired person (link), "high-pitch sounds become harder to distinguish, like electronic beeps and speech sounds such as “s” and “th.” Conversations can seem mumbled, and background noise feels distracting and invasive."

As I have written previously, hearing loss can be corrected but modern hearing aid devices are quite expensive. The modern hearing aid costs approximately $2000 apiece or about $4000 for a pair which is a lot of money. For that substantial sum, one acquires a sophisticated computerized electroacoustic system that performs a number of functions beyond amplifying sounds (with volume control). Using digital signal processing, noise is filtered, dynamic range extended, and directionality accentuated, resulting in improved speech intelligibility, selective frequency modulation, and feedback management. Not surprisingly under the current system, hearing aids need to be custom-programmed by a hearing care professional to suit your specific hearing loss and listening needs. Thus, a big part of the total cost goes beyond the device itself to the services provided by the hearing specialist. 

The high cost is particularly burdensome because standard Medicare does not cover hearing aids (although the House passed a bill last year that was not approved in the Senate to remedy the situation). Some Medicare Advantage plans will only partially pay the cost.

A cheaper alternative to hearing aids are personal sound amplification products (PSAPs) which can be considered stripped-down versions of hearing aids (QH). They may consist simply of a microphone, ampli­fier, and mini-loudspeaker. PSAPs are only available in standard settings and are not customized to the user although the higher-end PSAPs will have volume control. While hearing aids are considered medical devices and are regulated by the FDA (require FDA clearance), PSAPs are not and can be purchased over-the-counter at your local pharmacy for a price in the range of $10 to $500.

There is a big price and quality gap between a $5000 hearing aid and a $250 PSAP. Some have thought about filling that gap with over-the-counter (OTC) hearing aids that could be less sophisticated than prescription hearing aids and also circumvent the costs associated with the hearing specialist (i.e. testing and fitting). Last year the FDA announced a new rule that would make an OTC hearing aid a reality (FDA):

“Today, the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.” 

Importantly OTC hearing aids like prescription hearing aids are considered medical devices and need to be cleared by the FDA for safety and effectiveness. PSAPs, on the other hand as mentioned above, are considered consumer devices and are not subject to FDA oversight. 

The new rule which went into effect in October of last year, applies to those with mild or moderate hearing impairment. Those with more severe hearing loss should see a hearing specialist and become outfitted with a prescription hearing aid. To help consumers self-evaluate their own hearing, sellers such as Best Buy are offering online hearing assessment tests (Figure 1).  After the self-assessment, if you are still not sure whether your hearing impairment is mild to moderate versus severe, then you should see a doctor or hearing specialist.

From a consumer perspective, the experience of obtaining a hearing aid will change dramatically. It is now possible to walk into a pharmacy or retail store like Best Buy and purchase a full-blown hearing aid (perhaps missing some bells and whistles of prescription devices) for say $1000 total with no requirement for a prescription or session with a hearing specialist. Indeed Best Buy is planning to open hearing centers in more than 300 stores that will offer devices priced from $200 to $3000 which is in the range between PSAPs and prescription hearing aids. The experience may become more like buying an expensive pair of headphones rather than a medical device which could work well for many with mild/moderate hearing impairment. 

Time will tell how popular OTC hearing aids become. Regardless they fill an important gap between expensive sophisticated prescription hearing aids and inexpensive simple PSAPs. I expect the convenience (walking into Best Buy or maybe even Costco one day) and cheaper price to be compelling to consumers and enable the increased adoption of hearing aids.

Figure 1. Best Buy is offering an online hearing assessment test on their website that can help you determine whether you have mild/moderate or severe hearing loss. It involves listening to spoken numbers that are obscured by background static noise through your headphones.