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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  PSAPs are largely unregulated by the FDA, with the exception of draft guidance which restricts marketing PSAPs for the treatment of hearing loss.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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  • Darroch Cahen

    For those of us in the field of Audiology this is a must read.

  • Darroch Cahen

    Cynthia Compton-Conley; Where is the Print Button?

  • Kerri Chojnowski Goff

    No where does this article address the unique needs of children who are hard of hearing. Fitting infants and young children with appropriate hearing aids must be done by a trained pediatric audiologist because the brain is still developing. In addition, children with even a mild hearing loss are at a much higher risk of poor academic achievement and social isolation, quite simply because they missed out on all of the “passive learning” that their hearing peers and hard of hearing adults had by simply eavesdropping. Many private insurance policies consider hearing aids as a luxury item and not a prosthetic, which is really what they are…especially for a child who is still learning and developing. As the Mother of two children, both with a bilateral moderate to sever hearing loss, I can say that the costs for appropriate hearing aids are ridiculously inflated and frequently out of reach for those who need them most. Overall, great article, but please do not forgot about the small but much in need population of infants and children.

    • Cynthia Compton-Conley, Ph.D.

      Good point Kerri. I should have mentioned that this meeting was focused on adults with with mild to moderate loss, not children. Everyone is pretty much on the same page when it comes to kids. They need audiological care. I did talk to someone from a children’s hospital who did say that research is in the works for comparing PSAPs to hearing aids with some children. I think this effort is in response to the unaffordability of hearing aids for many.

  • aphoenix444

    There’s another elephant in this room that is completely being ignored.

    What about getting insurance companies to cover hearing aids? Why is this not part of the discussion? The best results in improving hearing are achieved when patients work with skilled providers to get a
    personalized solution that fits their hearing loss, lifestyle and physical capabilities. There are no one-size-fits-all hearing solutions. There are already plenty of inexpensive one-size-fits-all hearing enhancement options on the market, and if they could work for consumers, they’d already be working, people would be happy, and they would be flying off the shelves… but this is not the case. That is because our hearing is not one-size-fits-all, not even on both sides of the same head!

    Professionally fit hearing aids have over 90% satisfaction rate, and include far more than just the device. Better hearing is more than just a gadget you stick in your ear, as pointed out by this article. Many times it also involves counseling on realistic expectations and learning better communication habits, sometimes aural rehabilitation and even assertive listening devices are necessary as mentioned in the article. Routine cleaning, adjustments, hearing tests and repairs are also an incredibly important
    part of the equation, and most consumers are not capable of adequately performing these tasks. What happens when a $299 “hearing aid” gets plugged with a tiny bit of wax too deep for the consumer to see and remove but cutting off the sound? Does it end up in the drawer because it’s “broken” forcing the consumer to go buy another $299 “hearing aid” simply because there is no one who can properly maintain it? What kind of services are going to be included at that price point? None, and that is a disservice to the consumer because the services are just as important in achieving and maintaining better hearing as the device itself.

    Rather than cutting the professionals out of the equation to lower costs, how about we get insurance companies to treat hearing loss like the important medical condition that it is and cover both the devices and the services necessary to keep the hearing aids working long term? THAT is what would best serve consumers, but I notice it is nowhere in the discussion.

    • Cynthia Compton-Conley, Ph.D.

      You’re right. Insurance was not included in the discussion. Insurance is a complicated and important topic, but not relevant to the regulation or de-regulation of hearing aids. We all know that while some insurance does cover hearing aids, most don’t. I do recall hearing a Medicare official say that hearing aid prices need to be lowered before the government can even consider
      it. It’s maddening because hearing aid, while expensive, are oh so much less expensive than a cochlear implant, which is covered by insurance.

      Regarding the remainder of the discussion, I think what we are seeing is simply normal market disruption in action. Advances in technology, coupled with consumerism, are causing people to re-think how things are done. I, and many others, view this as the perfect opportunity for our profession to present a united front in making itself more known, standardizing best practices, and offering our services to patients who want to pursue traditional hearing aids and accessories as well as to patients who want try out OTC products (but who could be educated to use our services to
      verify whether or not the device is “good enough” for now and when it’s time to go with prescribed technology). This is why I like ADA’s reasoning.

  • CrimsonWife

    Instead of making aids OTC, the government should be mandating health insurance coverage of them. It is ridiculous that treatments for diseases caused by bad lifestyle choices are covered but hearing aids for my daughter’s genetic loss aren’t.

    • This would definitely be the best option for everyone. No OTC product will ever function as well as a professionally fitted device – *when best practices are used* – so the ideal solution is finding a way to subsidize hearing care. Sadly, this is a very complex issue and our government hasn’t been able to provide a cost-effective solution for taxpayers… This is very sad considering the documented economic cost of untreated hearing loss. Hearing loss, like education, should be heavily invested in to ensure a strong economy going forward.