A committee of the National Academies of Sciences, Engineering and Medicine has recommended that the Food and Drug Administration (FDA) change its rules on hearing aids that would make it easier for consumer technology vendors to establish a foothold in this multi-billion dollar market.
One of the recommendations calls for establishing a new category of over-the-counter (OTC) wearable hearing devices. The OTC device classification would be separate from hearing aids and would be defined as a wearable device that can assist adults with mild to moderate hearing loss. The committee also recommended that the FDA retain a guidance document on personal sound amplification products (PSAPs) that would establish a distinction between PSAPs for normal hearing and the OTC device category for hearing loss.
PSAPs, by law, can’t be labeled or promoted as intended to help with hearing loss (an ad in the AARP Bulletinsays “They’re not hearing aids”), but they’re popular with many people with mild hearing issues because they are much cheaper than hearing aids. A 2014 survey of the PSAP market by CTA found that the average price of one hearing aid was $2,363, with premium models costing $2,898. Behind-the-ear PSAP prices ranged from $200 (even less for some models) to $600.
Wide PSAP Support
Not surprisingly, several organizations have filed their positions with the FDA.
CTA has urged the FDA to open the market for PSAPs for people with mild to moderate hearing loss. CTA says its research found that the majority – 84 percent – of Americans with some level of hearing difficulty say they would go to a healthcare professional to address hearing loss concerns.
AARP supports making PSAPs more widely available, and has urged the FDA to withdraw its guidance, which it says “unnecessarily limits consumers’ ability to access PSAPs.” Bose Corp. says it believes that technical advances have made it possible for consumers to configure OTC hearing aids appropriately to their hearing loss without any expert-level knowledge about hearing or signal processing, and without intervention from a professional. (Disclosure: The author of this article wears prescribed hearing aids that are paired with a TV and smartphone via Bluetooth.)
In fact, some audiologists already recommend the use of PSAPs to patients with moderate hearing loss following an examination. According to the Academy of Doctors of Audiology, the FDA does not regulate the practice of audiology, and prescribing a PSAP is like selling any other consumer technology product.
Now Hear This
Hearing aids are a huge market. A Research and Markets Study projects global hearing aid sales will climb to $8.3 billion in 2020 from $6.1 billion in 2015, based largely on an aging population. AARP estimates that about 48 million Americans have measureable hearing loss. Will OTC wearable hearing or PSAP devices fall into the “wearables” market? How might this issue play out? Some regulatory specialists believe that even if the FDA adopts the National Academies committee’s recommendations, final rules that reconcile the three categories of devices; hearing aids, over-the-counter hearing aids and PSAPs, will be a year or more in the making.
For more information, see the President’s Council of Advisors on Science and Technology (PCAST) report.