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: FDA
The Over-the-Counter Hearing Aid Act of 2016, sponsored by Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa), would allow certain hearing aids to be sold over the counter and would eliminate the “burdensome requirement” that consumers get a medical evaluation or sign a medical waiver before purchasing OTC hearing aids. The Act would also require the FDA to issue regulations containing safety and labeling requirements for OTC hearing aids and to update its draft guidance on Personal Sound Amplification Products (PSAPs). The senators said they would introduce the legislation when Congress reconvenes before the end of the year.
This has been a huge year for consumers with hearing loss. The President’s Council of Advisors on Science and Technology (PCAST) issued a landmark (and highly controversial) report on the state of the hearing healthcare industry, with a focus on access to care, and hearing aid affordability. The Institute of Medicine (IoM) also held a four part “Committee on Accessible and Affordable Hearing Health Care for Adults.” The FDA’s regulation of affordable hearing aid alternatives was a hot topic of discussion at the IoM, and PCAST called for the deregulation of over-the-counter basic hearing aids. Meanwhile, the FCC is in the process of revising its Hearing Aid Compatibility (HAC) rules for mobile phones. Tech giant Apple has even become involved, asking the FCC to remove the telecoil requirement.
The Academy of Doctors of Audiology (ADA) applauds the President’s Council of Advisors on Science and Technology (PCAST) for its focus on using technology to remove barriers to care for the millions of Americans with hearing loss. ADA members are audiologists who have spent their professional lives evaluating, managing and treating patients with hearing and balance disorders. ADA is cognizant of the significant health implications of untreated hearing and balance disorders, and ADA wholeheartedly agrees that hearing loss is a public health issue that requires prompt attention.
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.”
IEEE P2650™, or the “Standard For Enabling Mobile Device Platforms To Be Used As Pre-Screening Audiometric Systems,” will undoubtedly become the defacto standard for all smartphone hearing-screening tests. The new standard will help IEEE achieve the goal of addressing the hearing needs of those in emerging economies, where diagnostic hearing-testing facilities, and hearing professionals, are in limited supply.
The President’s Council of Advisors on Science and Technology met on September 18th to discuss hearing aids and hearing technology. The discussion was led by Dr. Christine Cassel, MD, a leading expert in geriatric medicine, who suggested that “technology-based changes in Federal regulations … could make this [Personal Sound Amplification Product] technology more available and begin to promote more innovation in the market.” Here is a short snippet from Dr. Cassel’s professional bio, over at the National Quality Forum.
The center of the tech world finally seems to have discovered a technology that’s already at the center of many people’s lives: hearing aids. In recent months several hot Silicon Valley venture-capital-funded startups have emerged aiming to address one of the world’s biggest consumer technology opportunities — reaching the tens of millions of consumers with hearing loss who currently don’t use hearing aids.