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Milestones to OTC Hearing Aid Final Rule: Text Version

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2009, NIDCD Workshop, Accessible & Affordable Hearing Health Care for Adults with Mild to Moderate Hearing Loss

2010, NIDCD Funding Opportunity, Research on Accessible & Affordable Hearing Health Care (R24)

2010, 1st Congressional Report Language, “…NIDCD support research to develop, improve, and lower the cost of hearing aids…”

2014, NASEM Workshop, Hearing Loss and Healthy Aging workshop of the Forum on Aging, Disability, and Independence

2015, PCAST Letter, Report on age-related mild to moderate hearing loss

2016, NASEM Consensus Study, Hearing Health Care for Adults Priorities for Improving Access & Affordability

2016, FDA GMP Workshop, Streamlining GMPs for Hearing Aids

2017, NIDCD Informs Congress & OTC HA Act Introduced, Amendment to the Federal Food, Drug, & Cosmetic Act

2017, FTC Workshop, Examination of competition, innovation, and consumer protection issues raised by hearing health and technology

2018, 1st FDA Approved Self-fit HA, Marketing of first self-fitting hearing aid controlled by the user

2021, EO: Promoting Competition in the American Economy, “Save Americans with hearing loss thousands of dollars by allowing hearing aids to be sold over the counter at drug stores.”

2021, FDA Proposed OTC HA Rule, Landmark proposal to improve access to hearing aid technology for millions of Americans

Acronyms: Executive Order (EO), Food and Drug Administration (FDA), Federal Trade Commission (FTC), Good Manufacturing Practice (GMP), hearing aid (HA), National Academies of Sciences, Engineering, and Medicine (NASEM), National Institute on Deafness and Other Communication Disorders (NIDCD), over-the-counter (OTC); President's Council of Advisors on Science and Technology (PCAST)

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