OTC Device Standards & Regulations Hotly Debated at June 9th NASEM Meeting

June 12, 2017

By several accounts NASEM’s hearing health care report dissemination meeting, held June 9th in Washington, DC, was well attended and full of lively discussion on a range of issues related to accessible and affordable hearing care. According to a few of the meeting participants, the creation by the FDA of an over-the-counter (OTC) category of hearing instruments is no longer an “if,” but now seems to be a matter of “when.”

The June 9 meeting, chaired by Dan Blazer, touched on several topics that were part of the oft-cited June 2nd, 2016 Hearing Health Care for Adults: Priorities for Improving Access and Affordability report.

Breakout sessions at the June 9th meeting were devoted to:


  1. Public awareness and consumer measures (facilitated by Brenda Battat of HLAA),
  2. Quality metrics and health professional education (facilitated by  Judy Dubno),
  3. Innovation in services (facilitated by Frank Lin and Dan Blazer)
  4. Consumer comparisons – evaluation criteria and standardized terminology (facilitated by David Zapala of Mayo Clinic).


Among the topics discussed included an initiative to provide consumers with a single number, much like the vision industry, that quickly and easily summarizes a person’s hearing status relative to what is considered normal. In addition, according to attendees, one of the breakout groups debated the components of a pre and post intervention outcome assessment that takes into consideration functional communication in everyday living.

Readers are encouraged to engage on these topics with their professional organizations and to actively participate in the ADA’s upcoming Hackathon, which will allow participants to weigh in on a variety of pressing clinical topics.


Debating Details of Possible OTC Hearing Aid Category


During the June 9th meeting, Attorney Ellen Flannery also facilitated a discussion centering on the possible creation of a new FDA category of over-the-counter hearing devices. Specific topics covered during this OTC discussion included quality and safety requirements of this yet-to-be-created category of products. The Hearing Instrument Association (HIA) asserted it’s believe that if an OTC category is to be created it should meet the same FDA standards as existing hearing aids and should be offered only to people with mild hearing loss.


HIA also urged the FDA to review and finalize its 2013 draft Personal Sound Amplification Products (PSAP) Guidance document shortly to make clear that unregulated PSAPs cannot be marketed to address hearing loss.  


The Consumer Electronic Association (CTA) was also represented at last week’s meeting. Although the CTA is in favor of less restrictive regulations for amplification devices, the group has recently published a group of scientifically-defensible voluntary manufacturing standards and performance criteria for PSAPs.  

Hearing News will continue to monitor for any breaking news related to OTC issues.

  1. The Big Six will eventually market OTC hearing aids for people with mild hearing loss. But competition between them will cause them to increase the power of the hearing aids to serve people with severe hearing loss while they still advertise them to be only for people with mild hearing loss. This is how business works. Where am I wrong.

  2. If there’s no test of hearing or professional involvement at all why bother with standards? After all, 85% of the market is being thrown to the wolves.

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