In US, a committee on Accessible and Affordable Hearing Health Care for Adults for the National Academies of Sciences, Engineering and Medicine recommended that the Food and Drug Administration (FDA) establish a new category of over-the-counter (OTC) wearable hearing devices. This product does not fall into the classification of “hearing aids.” OTC wearable hearing devices is for adults with mild to moderate hearing loss.
U.S.-based trade body CTA has urged the FDA to open the market for hearing devices for people with mild to moderate hearing loss. Non-prescription hearing devices (currently referred to as PSAPs) can offer an affordable solution to the 98 million Americans experiencing some level of hearing loss, according to CTA. The difference between these two classes of devices is in the cost, a pair of hearing aid is priced around $1,000 to $6,000, whereas the OTC wearable hearing devices available in the range of $100 to $600.
"According to the National Institute on Deafness and Other Communication Disorders, only one in five people who would benefit from a hearing aid actually uses one," said Gary Shapiro, president and CEO, CTA. "That means millions of Americans needlessly suffer from hearing loss, simply because the high expense of hearing aids and doctors' visits keeps them from seeking help for their hearing - or they aren't aware of the immediate benefits PSAPs can offer. Given the extraordinarily high cost of hearing aids, consumers deserve the option of affordable and readily available PSAPs to improve their hearing and overall quality of life."
CTA is suggesting more of a market driven policies rather than tight regulations. Related to IOT market, it has suggested to regulation authorities "fragmented approach of IoT development would create a complex web of specific laws, rules and regulatory regimes that may not always be obvious and could be particularly difficult for smaller companies to navigate."