In recognition of the one-year anniversary of the U.S. Food and Drug Administration (FDA) making hearing aids an over-the-counter (OTC) product, the Hearing Industries Association (HIA) published an assessment of the state of the OTC market.

The HIA shared observations while reflecting on some of the goals behind the OTC hearing aid regulation: accessibility, affordability, and innovation. 

Further reading: OTC Hearing Aids Aren’t Attracting Buyers Yet

  1. Customer: The OTC customer is younger; wants a simple process without an appointment or prescription; is more of a situational user for meetings and social engagements; and is inclined to purchase from a brand they recognize.
  2. Market: Accessibility and competition are certainly there. More than 40 companies are selling OTC devices with over 80 companies filing registrations or 510(k) applications with the FDA.  A number of these devices were previously available as direct-to-consumer products and now can be obtained at retail stores, pharmacies, online, and even from some hearing care professionals.
  3. Branding and Partnerships: Some companies have recognized the power of a known brand. Some examples include the partnership between Nuheara and HP, WSAudiology and Sony, GN’s branding with Jabra, and Sonova’s acquisition of the audio division of Sennheiser
  4. Cost: Affordability is not an issue with prices ranging from $89.97 to more than $2,000. That is not to say that an OTC buyer understands the technology differences between a lower-cost hearing aid and a premium device. Secondly, they may not understand the potential benefits, or lack of, provided by many of the devices at the lower end of the price spectrum. 
  5. Insurance: Currently, it appears that insurance coverage for OTC hearing aids is very limited. Given how new the market is, insurance companies will need to adapt their plans. Over half of Medicare beneficiaries are currently enrolled in Medicare Advantage (MA), and almost all MA plans offer some type of hearing benefit. MA plans continue to innovate, and the HIA says it is closely tracking developments and changes. 
  6. Innovation:  There does not seem to be major new developments at this time except for some new form factors that are available or will soon come to market. Both prescription and OTC hearing aids share many of the same technological features including directional microphones; feedback reduction; noise suppression; rechargeable batteries; and wireless connectivity.
  7. Self-Fit Availability: The FDA regulations provided for OTC devices with pre-set listening environments such as quiet, TV, and noisy environments. It also provided a second category for Self-Fitting OTC devices, which the consumer can adjust using an app or online resources. The FDA requires self-fitting OTC devices to obtain clearance through the FDA 510(k) process before the device can be sold. This step takes time and resources and, so far, there are limited self-fitted devices available. It’s worth noting that the cost of these devices tends to be higher.
  8. Bad actors: A major concern is the proliferation of misleading advertising, unsubstantiated claims, and companies not following the guidelines in the FDA OTC regulation. Examples include claims of restoring natural hearing, treatment of severe hearing loss, and “invisible” hearing aids that use CIA technology. These examples, and more, have been raised with FDA to attempt to stem the rising tide of consumer confusion.
  9. OTC sales and returns: While the HIA tracks hearing aid sales for its members and provides a broad perspective of the market, no one is currently tracking OTC sales or returns. Some public information exists and reveals sales with returns of more than 30% for OTC devices. Some OTC buyers that receive some assistance from a hearing care professional or customer service representative may have higher rates of satisfaction and lower returns to the company than those buyers who receive no assistance at all.
  10. HIA Advice: If you are concerned about your hearing difficulty, you should schedule an appointment for a hearing test with a hearing care professional. You will learn the extent of your hearing loss and be able to explore whether an OTC or prescription device would best suit your individual needs.

Further reading: Study Shows Majority of Americans Neglect Hearing Health Despite Accessibility of Over-the-Counter Hearing Aids