During the FDA-hosted workshop on April 21st, stakeholders had the opportunity to provide input on 40-year-old FDA regulations and make recommendations for opportunities to enhance affordability and access to hearing aids and other devices for the treatment of hearing loss in the 21stcentury. Sparked in part by the recommendations contained in the PCAST Report: Aging America & Hearing Loss: Imperative of Improved Hearing Technologies, released in October 2015, the workshop was constructed to help the FDA better understand how it can appropriately balance patient safety while encouraging innovation and affordability.
ADA’s presentation, delivered by Dr. Alicia Spoor, provided FDA leaders with detailed information about current barriers to hearing care including awareness, an unclear pathway to care and affordability. ADA encouraged the FDA to consider changing anachronistic regulations that unduly restrict access to audiology services, place the FDA inappropriately in clinical practice and hinder innovation.
ADA recommendations included:
- FDA should remove the medical clearance requirement or, at a minimum, amend the requirement to include an audiologic evaluation.
- FDA should re-evaluate criteria used under current “intended use” doctrine for hearing aids to better account for actual use and downstream marketing, and rescind confusing guidance related to Personal Sound Amplification Products (PSAPs), and
- FDA should permit Class I, exempt hearing aids to be available over-the-counter (OTC) with appropriate labeling, restrictions and a strong recommendation to seek an audiologic evaluation before purchasing any hearing device.
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