Reading Glasses and Hearing Aids. Smart or FDA-Approved. Pick One.

Making Audio Augmentation useful for everyone, or pursue the regulatory requirements of OTC hearing aids. This article offers a useful perspective regarding the guidance documents published by the US Food and Drug Administration regarding improved access to hearing aid technology. The agency proposes a rule to establish a new category of over-the-counter (OTC) hearing aids - to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. But most audio manufacturers are better off by not pursuing this FDA-approved OTC market. Doing so will simply hinder critical experimentation and innovation.