Recommendations Outline Five Evidence-Based Safety and Effectiveness Priorities for FDA Consideration
Washington, DC – August 14, 2018: The major U.S. hearing healthcare professional associations (Associations) today announced the release of a consensus paper, “Regulatory Recommendations for OTC Hearing Aids: Safety and Effectiveness.” The consensus paper was developed by a working group representing all associations to provide guidance to the U.S. Food and Drug Administration (FDA) as it develops an over-the-counter (OTC) hearing device classification as mandated by the FDA Reauthorization Act of 2017 (FDARA). The consensus paper, which outlines five evidence-based recommendations related to the safety and effectiveness of this new class of devices, was jointly developed and endorsed by the Academy of Doctors of Audiology (ADA), American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS).
The associations appreciate FDA’s recent statement that Section 709 (of FDARA) reflects a careful balance between consumer affordability and access to new technologies, while providing consumer protections to assure safety and effectiveness of OTC hearing aids. The consensus paper introduction, in part, states, “[The Working Group] strongly advocates that any solutions presented to the consumer rely on safe and effective medical devices and include safeguards that optimize consumers’ awareness and use of appropriate hearing care treatment.”
The consensus recommendations address: 1) the product requirements appropriate for OTC hearing devices targeting mild to moderate hearing impairment; 2) outside-of-the-box labeling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labeling; 4) naming the products Self-Fit Over-the-Counter Hearing Devices, adopting risk classifications consistent with air conduction hearing aids, and limiting 510(k) exemptions; and 5) establishing strong consumer protection laws.
The Associations are committed to jointly engaging with the FDA and other stakeholders in the coming months and years, during the continued development of the new OTC hearing device classification.
On the release of the consensus paper, the Association presidents made the following statements:
- “The Academy of Doctors of Audiology is pleased to collaborate on the development of consensus recommendations that will help ensure that the Over-the-Counter Hearing Aid Act is implemented by the FDA as it was intended by Congress,” said Alicia Spoor, AuD, ADA President. “ADA has been a longstanding advocate for expanded consumer choice and best practices in the delivery of hearing and balance care, and it is extremely gratifying to see alignment within the provider community towards achieving these goals.”
- “This collaborative effort among the American Academy of Audiology and various hearing associations is just one step in ensuring that consumers and federal regulators are aware of the value of the audiologist for advanced diagnostic testing, hearing and balance evaluations, rehabilitation, and technological expertise,” said AAA President Jackie Clark, PhD. “The Academy looks forward to continuing this work to ensure that the safety of the patient is prioritized by the FDA as they develop regulations on over-the-counter hearing devices.”
- “The American Speech-Language-Hearing Association has welcomed the opportunity to work with fellow hearing professional organizations on a development as important as the introduction of a new category of hearing aids,” ASHA President Elise Davis McFarland, PhD, CCC-SLP said. “I urge the FDA to follow our consensus report recommendations. Drawn from years of experience providing hearing care, they stand to contribute significantly to meeting the goal of ensuring safe and effective use of Self-Fit OTC Hearing Devices.”
- “The International Hearing Society stands with the other professional associations in recommending well-reasoned and thoughtful suggestions in the consensus paper on Self-Fit OTC Hearing Devices for the FDA to use in formulating the rule,” said Richard Giles, ACA, BC-HIS, IHS President. “We look forward to jointly engaging with the FDA and others to develop the appropriate regulatory structure and requirements, so these new devices will be both safe and effective for consumers.”
The consensus paper has already received endorsement by Hearing Industries Association.
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