Nuheara introduced hearables at CES 2018 that would not have been legal six months earlier. IQbuds Boost‘s Ear ID hearing threshold calibration analysis software incorporates National Acoustics Labs‘ NAL-NL2 self-fit protocol. NAL-NL2 is an international, industry-recognized standard used by audiologists to prescribe hearing aids to make speech intelligible and overall loudness comfortable. Audiologists and representatives of established hearing organizations spoke against passage of the law that makes it possible for Nuheara to sell IQbuds Boost directly to consumers “over the counter (OTC).” The argument was that all hearing loss is individual and that people with moderate to severe hearing loss, thresholds not covered by the new law, would be misguided to buy OTC solutions. However, the existing structures and systems weren’t serving enough people. Government estimates that only 20% of people with impaired hearing sought help due to the costs of medical exams and hearing aids led to the Over the Counter Hearing Aid Act.

Senator Elizabeth Warren presented the bill to the U.S. Senate in March 2017. Signed into law five months later, the act requires that the Food and Drug Administration “categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids.” The OTC law works in conjunction with the earlier elimination of a long-standing FDA requirement that consumers either have a medical examination or sign a waiver before obtaining a hearing aid.

We wrote about Nuheara’s original IQbuds last year. Nuheara’s product was one of several hearing-assistive hearables expected to debut in 2017. When anticipated hearables from other companies either failed to make it to market or, as in the case of Doppler Labs’ Hear One, had poor battery life {leading the company to shut down), Nuheara’s well-received IQbuds remained as the major player in a vast field. Speaking from my personal experience with IQbuds, you set up a personal profile by selecting amplification levels and equalization settings for each ear. You can also configure a balance between environmental sound and speech. I found the IQbuds very helpful with my high-frequency hearing loss and tinnitus, particularly in situations such as understanding tablemates’ conversation in crowded restaurants. However, I know the settings weren’t exact because I made them by trial and error. Nuheara’s Self-Fit calibration software uses artificial intelligence to create a personalized profile based on hearing thresholds.

Pricing has not yet been announced for IQbuds Boost, but they are certain to be higher than the original product’s $299 cost. Nuheara expects to start shipping IQbuds Boost in March 2018.