Loud and clear: Affordable OTC hearing aids could become a future reality

5/17/2017
More than two-thirds of baby boomers over the age of 60 reported some hearing loss, or the inability to hear high-pitched sounds, according to the most recent National Health and Nutrition Examination Survey. And that’s cause for concern, as the Journal of the American Geriatric Society has projected that the cost for the first year of hearing loss treatment in older adults will reach $51 billion nationwide by 2030.

The Federal Trade Commission cited a recent report by the National Academies of Science, Engineering and Medicine, estimating that “67% to 86% of adults who may benefit from hearing aids do not use them” because of the exorbitant price.

In December, the Food and Drug Administration indicated its intent to explore hearing aid label options for nonprescription products, creating a potential new niche opportunity for retail pharmacy. “[These] actions are an example of the FDA considering flexible approaches to regulation that encourage innovation,” said then FDA commissioner Robert Califf. “The guidance will support consumer access to most hearing aids, while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids.”

In April, the FTC held a hearing regarding personal sound amplification products, or PSAP. Bill Belt, senior director, technology and standards at the Consumer Technology Association, suggested PSAPs be held to minimum performance standards that the consumer electronics association drafted earlier this year. The association is currently exploring a “seal of approval” that would signify whether PSAP meets that standard.
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