The FDA was scheduled to issue regulations on over-the-counter hearing aids last August. Kevin Franck, vice-chair of the Board of Directors of HLAA, will discuss where we are with OTC hearing aids. Factors the FDA is considering include who the aids are intended for, issues about labeling, place of sale, and so on. What are various interest groups, including HLAA, hoping to see in the regulations? Meanwhile, what is filling the gap left by the FDA's failure to regulate?