Hearing aid user instructional brochures
This article was originally published in The Gray Sheet
Executive Summary
FDA requests comments by Oct. 25 on whether requiring hearing aid manufacturers to produce and distribute user brochures would be overly burdensome. The notice increases the agency's earlier estimate of the number of hours required to produce each brochure from 40 to 102 staff hours. However, the agency maintains its view that each hearing aid model requires only one brochure, despite comments to the contrary submitted by the Hearing Industries Association last August. HIA estimated the total hours per brochure at 136, charging FDA with "grossly" underestimating the regulatory burden of the requirement