American associations reach collaborative consensus on OTC guidance


Four major hearing healthcare professional associations in America have worked together to draw up a list of recommendations for the new Over-the-Counter hearing aid classification and provide guidance to the US Food and Drug Administration (FDA).

A consensus paper has been developed by a working group of representatives from the Academy of Doctors of Audiology (ADA), American Academy of Audiology (AAA), American Speech-Language-Hearing Association (ASHA) and International Hearing Society (HIS). A fifth group, the Hearing Industries Association (the representative body for manufacturers), has also endorsed the consensus paper.

The consensus paper provides five evidence-based recommendations which relate to the safety and effectiveness of Over-the-Counter (OTC) products. The five areas covered are: 1) the product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment; 2) outside-of-the-box labelling appropriate for medical devices sold over-the-counter; 3) comprehensive inside-the-box labelling; 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 engaging with the FDA to ensure that “any solutions presented to the consumer rely on safe and effective medical devices and include safeguards that optimise consumers’ awareness and use of appropriate hearing care treatment.”

Jackie Clark, PhD., AAA President says, ““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.” She continues, “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 complete, 36-page, consensus paper can be found at