Part Two in the PCAST Series: Innovative Technologies and Disruptive Business Models in Hearing Loss

Hearing loss is a complex topic that is tough to adequately capture in a blog post.  Consider this post a primer on the key facts and associated regulatory and market issues as well as the barriers to consumer adoption of hearing loss solutions.

An October 2015 PCAST report on hearing loss laid out the following grim facts on hearing loss:

  • 25% of adults between 60 and 69 years, 50%+ in the range 70-79 years, and almost 80% of those older than age 80 have difficulty hearing – that is almost 30 million people in the U.S.!
  • The average person has been having trouble hearing for 7-10 years before they get it checked out
  • Untreated hearing loss is statistically associated with higher risks of social isolation; depression; dementia; falls with injury; and inability to work, travel, or be physically active
  • Only 15-30% of Americans with hearing loss seek out and use assistive hearing technologies
  • Hearing aids are prohibitively expensive - the average price of just one hearing aid in 2014 was $2,363, with premium models costing nearly $3,000
  • Hearing aid components are estimated to cost less than $100 to manufacture and produce
  • Medicare rarely covers the costs of hearing aids so consumers typically pay out of pocket
  • The stigma associated with wearing hearing aids is another major barrier to adoption
  • 12-18% percent of the 3 million hearing aids sold in the U.S. each year may end up not being used due to poor fitting and other adoption challenges

Innovation in the hearing industry – both for product features and business models – has been lacking.  This is due to a number of factors:

  • The industry is highly concentrated with just 6 hearing aid manufacturers dominating 98% of the global market for the last 15 years
  • Distribution channels and reliance on audiologists to diagnose and treat hearing loss (who are incentivized to sell select brands) have reduced consumer choice by creating barriers to access multiple brands and models
  • Some states require in-person sales and prohibit mail and Internet orders, which can be more affordable and convenient

There are a number of steps that the government and industry can take to improve treatment of hearing loss and adoption of hearing aids and devices.

  • Run marketing campaigns and public service announcements to reduce the stigma associated with hearing loss and aid in prevention – Identify celebrity endorsers and promote free earplugs at loud events/activities (i.e., concerts, spin studios, etc.)
  • Promote hearing testing early and often – Certify and market hearing aid tests and make them accessible online or via smart devices.  Provide incentives to primary care physicians (PCPs), other providers and employers to recommend and perform hearing tests (currently very few PCPs conduct hearing tests)
  • Relax regulations on FDA requirements for medical evaluations to purchase hearing aids – The FDA currently requires that consumers undergo a medical evaluation to purchase any kind of hearing aid.  Relaxing this requirement and allowing consumers to purchase basic hearing aids over the counter may allow consumers to better treat and self-manage their hearing loss
  • The Federal Trade Commission should work to promote more consumer choice – Nearly 80% of hearing care professionals bundle diagnostic and treatment options.  Not only do many patients not use all the services in a bundle, but it also prevents them from comparison shopping for better options.  The FTC ended such bundling practices for eyeglasses in 1978 and similar changes to bundling practices for hearing care will provide more consumer choice.
  • Leverage innovative technologies to reduce the cost of manufacturing and improve convenience – Use 3D printing to create custom earbuds and configurations; develop “hearables” (wearables that assist with hearing to offer things like forgotten names (via face recognition), health alerts (Fitbit equivalents), and navigational information (indoor and outdoor GPS)); and utilize computational power to make assistive devices more effective
  • Withdraw FDA’s draft guidance on Personal Sound Amplification Products (PSAPs) – PSAP devices, which aren’t defined as hearing aids, serve many of the same functions as hearing aids and have experienced greater innovations and cost reductions than traditional hearing aids.  The FDA does not regulate PSAPs as they do hearing aids; however, in 2013, the FDA drafted guidance that would thwart PSAPs’ ability to truthfully market claims that they assist with hearing amplification. Such guidance will seriously stymie PSAPs’ ability to reach consumers, their business model and their efficacy in treating hearing issues.

In short, there are a number of complex societal, regulatory and market forces that make consumer adoption of accessible, affordable and attractive hearing solutions very challenging.  It is time for the public and private sector to work together to do what is best for the consumer and address our nation’s growing hearing problem.