Posted by - For Consumers, Regulation.


On October 26th, 2015, we noticed a very interesting status update on IEEE Standards Association’s Facebook page. See below or view on Facebook.

For those that don’t know, IEEE, also known as the Institute of Electrical and Electronics Engineers, is the “world’s largest professional association advancing innovation and technological excellence for the benefit of humanity.” One of IEEE’s fundamental activities is developing the “international standards that underpin many of today’s telecommunications, information technology and power generation products and services.”

IEEE P2650™, or the  “Standard For Enabling Mobile Device Platforms To Be Used As Pre-Screening Audiometric Systems,” will undoubtedly become the defacto standard for all smartphone hearing-screening tests. The new standard will help IEEE achieve the goal of addressing the hearing needs of those in emerging economies, where diagnostic hearing-testing facilities, and hearing professionals, are in limited supply.

Considering the recommendations made this week by President’s Council of Advisors on Science and Technology (PCAST), one has to wonder whether the IEEE also intends to address the problems at home, in the United States.

President's Council of Advisors on Science and Technology

Read more about the PCAST Meetings

To address issues of hearing-aid affordability, PCAST’s letter to the president proposed that the FDA create a distinct category of “basic” hearing aids, defined as “non-surgical, air-conduction hearing aids intended to address bilateral, gradual onset, mild-to-moderate age-related hearing loss.” Importantly, PCAST also stated that “consumers should be able to self-diagnose” their condition, directing the FDA to permit the sale of consumer-driven hearing-screening software. Such software could be available for purchase in stores, online, or as smartphone hearing test apps.

While the timing of IEEE’s announcement may be coincidental, it may prove impeccable. If the FDA acts upon the PCAST recommendations, there could soon be a flood of over-the-counter (OTC) “basic” hearing aids. It is in the best interest of consumers everywhere to have a well-established standard developed by IEEE before this happens, as consumers will be less likely to damage their hearing with poorly-developed test software, and more likely to achieve success with OTC products. After all, if the OTC “basic” hearing device does not understand the user’s hearing impairment, it is very unlikely to prescribe the sound levels needed to bring back adequate audibility for sound.

Should the FDA allow “basic” over-the-counter hearing aids? Please complete this short survey.

Last modified: