Today, the FDA issued the “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids,” which effectively ends federal enforcement of the hearing aid medical waiver. For those in the dark, the hearing aid medical waiver is a waiver that may be signed in lieu of having the required pre-hearing-aid-purchase medical evaluation.
Posts Tagged: over-the-counter hearing aids
In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) delivered Aging America & Hearing Loss: Imperative of Improved Hearing Technologies, which targets America’s worsening hearing loss epidemic. The report proposes a number of regulatory changes, at the level of the Federal Trade Commission (FTC) and Food and Drug Administration (FDA), which PCAST believes will “decrease the cost of hearing aids, spur technology innovation, and increase consumer choice options.”