Getting Up to Speed on OTC
Since the new FDA regulations for over-the-counter hearing aids went into effect last month, there have been many questions and comments about them. Such questions as: How might OTC devices differ from prescribed hearing aids? Where can consumers buy these products? What exactly do the regulations say about how they are to be manufactured and…
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FDA Offers Clarification to States Regarding Final OTC Hearing Aid Rule
WASHINGTON, D.C. — Today, the U.S. Food and Drug Administration (FDA) sent a letter to state officials offering clarifications about the Final Rule on OTC Hearing Aids, following requests by several professional organizations seeking to better understand the distinction between ‘Prescription’ and ‘OTC’ hearing aid categories. In part, the letter states, “We have received questions about…
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Auditory Insight Urges Hearing Health Executives to Size OTC Market Now
NEW HAVEN, CONNECTICUT — Auditory Insight, a leading consultancy for the hearing healthcare industry, has created a proprietary process for calculating the OTC hearing aid market size. Developing addressable market size has new urgency now that the FDA has released a final rule for a new OTC hearing aid category. The final rule contains the product specifications…
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Final OTC Hearing Aid Regulations Inch Closer to Reality After White House OMB Concludes Review
The long-awaited Over the Counter (OTC) hearing aid regulations appear to have taken a step closer to reality this past week. On August 5th, the White House Office of Management and Budget’s OIRA department (Office of Information and Regulatory Affairs) completed its review of the final rule. According to OIRA, the final OTC rule was…
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Grassley, Warren Introduce Bill to Increase Pressure on FDA to Issue Final OTC Hearing Aid Rule
WASHINGTON, D.C. — Today, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) introduced new legislation that would require the Food and Drug Administration (FDA) to issue a final rule regarding over-the-counter hearing aids. Their bipartisan Delivering Over-the-Counter Hearing Aids Now Act follows the FDA’s proposed rule implementing over-the-counter hearing aids in October 2021, which was…
Read MoreSenators Grassley and Warren Urge FDA to Take Immediate Action on OTC Hearing Aid Rule
WASHINGTON, D.C. – In a letter to U.S. Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) expressed their support for key provisions in the FDA’s proposed rule for regulating over-the-counter (OTC) hearing aids. The FDA’s proposed rule is a direct result of the Over-the-Counter Hearing Aid Act,…
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Starkey’s Brandon Sawalich Issues Statement Regarding President Biden’s Competition Executive Council Announcement
Starkey President and CEO, Brandon Sawalich has issued a statement following comments from President Biden regarding the Competition Executive Council. In releasing the statement, shown below, Starkey reiterated that the company “supports increasing hearing aid accessibility, but not at the cost of patient safety”. “Hearing aids are a medical device. They are built with the…
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Auditory Insight Assesses Impact of FDA Proposal for OTC Hearing Aids
NEW HAVEN, CONNECTICUT — Auditory Insight, a leading consultancy for the hearing healthcare industry, analyzes the impact of the FDA’s recently proposed rule for over-the-counter (OTC) hearing aids in a special research bulletin. Download the research commentary: New FDA Proposal for OTC Hearing Aids The Over-the-Counter Hearing Aid act, passed in 2017, directs the FDA to create…
Read MoreFDA Proposes Rule to Create New OTC Hearing Aid Category
Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold…
Read MoreSenators Call on FDA to Issue Over-the-Counter Hearing Aid Regulations by November 6th
WASHINGTON D.C. – United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) urged the Food and Drug Administration (FDA) to issue new regulations for over-the-counter (OTC) hearing aids without delay, in accordance with President Biden’s Executive Order on Promoting Competition in the American Economy and their bill, the Over-the-Counter Hearing Aid Act, which was signed into law over…
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