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FDA Elephant

Last Thursday’s Food and Drug Administration (FDA) Public Workshop on whether the FDA regulations on hearing aids should be relaxed in an effort to lower costs to consumers, addressed a number of controversies surrounding the disruptive forces in the hearing healthcare marketplace, including (1) consumer demand for more affordable and easily accessible hearing health care and (2) hearing enhancement options that can be purchased outside the traditional hearing health care marketplace.

Much of the discussion hinged on how the FDA looks at hearing aids versus PSAPs (Personal Sound Amplification Products). The FDA classifies hearing aids as regulated medical devices.  PSAPs are largely unregulated by the FDA, with the exception of draft guidance which restricts marketing PSAPs for the treatment of hearing loss. PSAPs may be marketed only to those with normal hearing who wish to have their hearing enhanced.

PSAPs and hearing aids pretty much look alike and do exactly the same thing: They amplify sound. And, just as certain hearing aids can be used with wireless remote microphones, so can some PSAPs. Some PSAPs even contain telecoils, thus making them function as wireless receivers when used with a room loop installed in a living room, boardroom or movie theater. It’s not surprising many are asking why a PSAP, which is like a hearing aid, can be marketed to normal hearing individuals to hear better when hunting or listening from a distance, but cannot be marketed to people with hearing loss for purposes such as hearing the TV better or for understanding in noise?

So the FDA posed the following questions:

  1. What are the barriers to hearing aid access?
  2. How can hearing aid access be improved in the U.S.?
  3. What is the consumer perspective on improving access to hearing aids in the U.S.?
  4. Do FDA regulations create a barrier to hearing aid access? And if so, how?

The President’s Council of Advisors on Science and Technology (PCAST), the National Academy of Sciences, Engineering, and Medicine Committee on Accessible and Affordable Hearing Health Care for Adults, and the FDA all made presentations.  The audience also heard from various stakeholders including hearing aid manufacturers, the consumer technology industry, audiologists, hearing aid specialists, otolaryngologists, and consumers.

As I listened, three viewpoints emerged:

  1. Maintain the status quo. Only hearing aids should be used to treat hearing loss. PSAPs should not be used to treat hearing loss as, and adults with mild to moderate hearing loss cannot manage their own hearing care.  Hearing aids should be fitted by audiologists and hearing aid dispensers, following medical clearance or a waiver.  This view is held by the hearing aid industry and by some, but not all, hearing health providers.  Some see this view as protectionism (of the hearing aid and hearing health care industry) and as a barrier to innovation and affordability.
  2. Let consumers choose; they are smart enough to figure it out. The FDA should designate a basic hearing aid for over-the-counter (OTC) sale (similar to reading glasses), without the requirement for consultation with a credentialed dispenser. The FDA should also exempt OTC hearing aids from regulation and substitute compliance with standards for product quality and record-keeping appropriate for the consumer electronics industry. This view is held by the President’s Council of Advisors on Science and Technology (PCAST) and by some consumers and providers.  PCAST was formed to develop recommendations for affordable hearing health care.  Some see this view as forward thinking as it embraces today’s consumerism.  Others feel it could create consumer risk because buying OTC hearing enhancement products without hearing assessment may be dangerous and because not all consumers are tech savvy, do-it-yourselfers.
  3. A measured approach. The FDA should create a class of OTC hearing aids, but these products should “be very specifically labeled and include a strong recommendation that a patient seek a comprehensive evaluation from an audiologist or physician prior to purchasing any device for the treatment of hearing loss, especially if the patient exhibits any of the warning signs of ear disease.”  This view was presented by the Academy of Doctors of Audiology (ADA) who support the PCAST recommendation and the use of both OTC and audiologist-prescribed hearing enhancement technologies, but also support the need for proper diagnosis and assessment of hearing.  ADA acknowledged that since the current medical waiver is being used indiscriminately, the medical clearance required by the FDA should be eliminated or amended to include a requirement of an audiologic evaluation.  ADA’s complete response to the PCAST can be read here.

As a long-time audiologist and consumer advocate who supports patient-centered care and standardized best practices, I resonate with what the ADA had to say.  Their view embraces the inevitable advancement in technology toward universal design and supports the best interest of consumers seeking hearing help. Increasing numbers of technologies will be made available that can help people hear well.  While this creates choice, it also can create confusion.  As Alicia Spoor, ADA treasurer, asked pointedly in her presentation to the FDA, how does a consumer know if a certain technology will work best for his or her hearing needs?

Dr. Spoor’s question reveals the elephant in the room.  The discussion should not be about hearing aid access.  It should be about hearing access.  People don’t seek hearing aid access.  They seek hearing access.  This is an important conceptual distinction because hearing needs should inform technology choice.

Needs assessment is a complex task that involves holistically and systematically assessing each person’s hearing goals within the context of  lifestyle – at home, in the workplace, at school, and when out and about in the community.  Focusing solely upon hearing aid (or PSAP) access is merely a point solution, and point solutions ignore related issues such as the interaction of a person’s hearing loss with lifestyle, room acoustics, cognition, dexterity, finances and a whole host of other factors.  The key is that the technological solutions are not always hearing aids, and this is a key point that the FDA seems to be missing when they pose the question: “What are the barriers to hearing aid access?”

Having worked with thousands of people with hearing needs over the years, I can say with confidence that the best technology solution for each person can be taken from a wide range of products.  It could be hearing aids.  It could be PSAPs.  It could be hearing aids (or PSAPs) used in conjunction with hearing assistance technology such as a wireless remote microphone.  It could also be hearing aids or PSAPs equipped with telecoils and used with a room loop to facilitate better hearing in a public venue such as a lecture hall or movie theater.  It also could be captioning or some sort of alerting device to allow someone to be aware of certain warning sounds.

It’s time to open the market for innovation and embrace any and all technologies being developed to help people hear better. But let’s do it in a transparent way that places consumer needs front and center.  If OTC products are allowed, they should include labeling that explains what they can be used for and what they cannot.  Every OTC product should be accompanied by performance standards so that consumers can easily compare the quality of one product with another. Labeling should also advise consumers of the importance of having an audiological assessment.  While some people can figure out what to purchase on their own, others may have more complex needs and may require the guiding hand of an audiologist who can provide comprehensive audiological evaluation, needs assessment, selection, verification, and validation of technological and behavioral solutions chosen to meet their unique hearing needs/lifestyle.

Editor’s note:

Regardless of what the FDA decides, Hearing Tracker is committed to providing consumers, and the audiology community, with continuous objective coverage of the full spectrum of available hearing enhancement technologies.

Cynthia Compton Conley

About Cynthia Compton-Conley

Cynthia Compton-Conley, Ph.D. is an audiologist who has had a distinguished career as an educator and consumer advocate. From vacuum tubes to Bluetooth®, she is unquestionably best known for expanding awareness of assistive technology for people with hearing loss. An acclaimed expert in this specialty area, her counsel and advice are sought worldwide. Visit her website for audiology consulting to learn more.

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