Back to the Future: Current Thinking at the FDA and in the Marketplace
The burden of regulation continues to haunt the hearing aid industry and cost consumers. Notwithstanding the entrenched regulatory mentality described in Parts 5 and 6 of this series, there were two interesting Citizen’s Petitions that were filed with the FDA in 2003. Their purposes were to eliminate medical clearance requirement and create a new class of Over the Counter (OTC) hearing aids. The first petition made the point that:
“the actual risks of skipping the [medical] exam are extremely small and rarely fatal. As one indication of how small the risk is, we allow consumers to assess the risk themselves and sign a waiver.”
The second petition described OTCs as “one size fits most” devices that could retail for around $100. Although neither petition was approved by the FDA, they ushered in a new way of thinking for the industry, consumers, and regulatory bodies. That thinking reflected technological movement in the industry, market demands for improved means of hearing communication that emulated and anticipated some of the ear-level devices coming into vogue with normal listeners (e.g., cell phone and ipod ear tips, Bluetooth ear level devices), and prices that reflected a wide variety of consumer tastes and product qualities demanded. A paper presented at a 2008 OECD conference called for a
“rigorous re-appraisal of hearing aid regulation… that would focus on both costs and benefits of increased availability of alternative products (e.g., over-the counter).”
Ironically, after their brief but intense foray into the world of medical devices, hearing aids seem once again poised to resume their role as personal hearing enhancers for any and all (see Parts 1 and 2 of this series). At the time of writing, the 1977 FDA Final Rule remains in effect, yet the FDA itself seems to be looking the other way these days and carving out a new type of device for which it eschews jurisdiction.
For instance, the image at the top of this post is a device that amplifies sound, inserts into the ear, is available online at a very low cost, and does not require warnings, medical clearance, waiver, or user instruction brochure. In every way, it appears to be a hearing aid: it is an ear-level device equipped with a receiver, an amplifier, a volume control, a battery, a microphone, and a tip that inserts into the ear. It is available at amazon.com without regulation for $8.99 , where it is found by entering “hearing aid” as the search term on their website. The public, industry, and hearing professional are justified in wondering how this can be, if the FDA rejected the Citizen’s Petitions described above?
The answer to this rhetorical question lies in a 2009 FDA publication, entitled “Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.” That novel publication takes on the task of resolving least burdensome issues for conforming to existing regulations. Toward that end, the publication provides the following definition and explanation of a new device the FDA calls a Personal Sound Amplification (PSAP).
“PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are not intended to compensate for hearing impairment [but are typically used for]… soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers and listing of these products with FDA.”
It seems likely that the hearing aid, as we know it and as a medical device, is headed toward extinction in coming years as technological improvements result in OTC products that satisfy a wide swath of the hearing and hearing-impaired markets. For example, a new phone app called EarTrumpet for iPhone and iPad devices is promoted for people with hearing impairment as having “the capability to enhance and adjust sound to discretely improve (e) your hearing experience.”
As PSAPs dominate the market, the Final Rule will become archaic and of historical interest only. It seems more than possible that the long-ago claims of many in the field at the time of the 1977 Final Rule may be borne out by market processes – that hearing loss was never a medical problem for most consumers; rather it was a normal part of the aging process and deserved to be treated as such.