Can You Hear Me Now?

Big news in DIY health.  Scratch that: big news in health, period.  The FDA just approved the Bose Hearing Aid, "the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider." 

If that doesn't sound like big news, you must not have known anyone with a hearing aid.  Or you doesn't yet realize the broader implications of the approval.  DIY is coming for healthcare.

Credit: Audicos

Let's start with hearing aids.  Almost 40 million Americans report having trouble hearing, with the prevalence of hearing loss highest for those over 65.  As few as 20% of those with hearing loss actually get hearing aids, in no small part due to their cost. 

Traditional hearing aids are expensive.  Not hospital stay expensive, not immunosuppressive drug expensive, but typically several thousand dollars, and not usually covered by health insurance or Medicare.  There's a whole process of being tested by licensed audiologist, getting a prescription, being fitted, and, of course, often paying for it out of pocket. 

All that may change.  The FDA approved the Bose hearing aid under its De Novo premarket review pathway, which is "a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device."  The pathway was made possible by the 2017 Over the Counter Hearing Aid Act, aimed to make it easier for consumers with mid-to-moderate hearing loss to get hearing aids. 

The FDA reviewed data from 125 patients, comparing the outcomes of their self-fitting the Bose device to being professionally-fitted, and found them comparable; in fact, patients prefered their own settings over those done by the professionals. 

In most cases, consumers may still need to be tested by an audiologist and get a prescription from one.  Things will really heat up in 2020, when the FDA is expected to issue regulations that will allow consumers to bypass those steps. 

Stocks for leading hearing aid manufacturers took an immediate hit following the FDA announcement.  Bernstein analyst Lisa Bedell Clive wrote: 

In our view, how big of a threat the OTC channel will be to traditional hearing aid companies in part depends on the entrance of consumer electronics players, with their strong brands and significant marketing muscle.  It will be interesting to see if this is the first of a number of new entrants. For instance, we know Samsung has looked at hearing aids in the past.”

We've already seen a wave of Personal Sound Amplification Products (PSAPs) that can't be marketed as hearing aids but which attempt to solve the same problems, especially for those with only low or moderate hearing loss.  For example, Bose has its Hearphones and LifeEar offers CORE and BOOST. 

Think the Apple Watch is nifty, especially with its FDA-clearance for heart monitoring?  Wait for the Apple Earbud that serves as a hearing aid. 

We're already inching towards DIT audiology.  Audicus offers an online hearing test, which its in-house audiologists use to tailor hearing aids that are priced well below $1,000.  As founder and CEO Patrick Freuler told Crain's New York Business, "You can do everything from home with a few clicks of a button."  

Mr. Freuler plans to partner with pharmacies, offering the tests there, with the hearing aids available literally off-the-shelf.

Not surprisingly, the audiologists are not happy.  Audiologist Salvatore Gruttdauria told Crain's: "However, with a model like that, you're going to miss a lot of diseases and disorders that, No. 1, could possibly be treated and, No. 2, could have some serious medical consequences."  Mr. Freuler counters by noting that the vast majority of people who need hearing assistance never see an audiologist, much less get hearing aids, due to the time and trouble involved.  

Get used to those kinds of arguments.

Credit: Opernative

Lest you think this is all only about hearing, you can already take online vision tests, such as through Opernative or millennial favorite Warby Parker. 

As if those are not impressive enough, consider OpenAPS -- the open source artificial pancreas system.  Launched in 2015, it helps people build their own systems to communicate between insulin pumps and glucose monitors.  The systems are not approved by the FDA.

Reuters reports 725 people using such a system, and that the system "appears to improve outcomes among people with type 1 diabetes."  Dr. Michelle L. Litchman, of the College of Nursing at the University of Utah, told Reuters: 

People with diabetes and their caregivers (ie, parents) are crowdsourcing solutions to enhance diabetes technology because they perceive industry and FDA have not met their immediate needs.  Although unconventional, OpenAPS is forcing conversations around the speed in which diabetes technology is developed and approved."

Dr. Norman Waugh from Warwick Medical School (UK) had some advice for physicians and others who were resistant to the movement: "Support it and be prepared to learn from the OpenAPS people."  

Dr. Joyce Lee -- Doctor as Designer -- sees a broader trend, telling Reuters: 

The DIY artificial pancreas could be considered a novel example of personalized medicine.  We are only going to see more examples of this in an era of patient autonomy, mobile computing, and peer-to-peer learning through social media.

Heck, there are even attempts at DIY dentistry, such as through SmileDirectClub or Australia's EZ Smile.

MIT thinks enough of the DIY movement to sponsor the Little Devices Lab.  It's mission:

We develop empowerment technologies for health. We believe that innovation and design happens at the frontline of healthcare where providers and patients can invent everyday technologies to improve outcomes. By radically democratizing the tools of medical creation, we seek to enable front line patients and providers to invent answers to disease burdens.

I especially love the "radically democratizing the tools of medical creation."

Ampli diagnostic blocks, credit: MIT Little Devices Lab

This is cool stuff.  This is scary stuff.  This is what happens when the traditional healthcare processes produce results that take too long, are too expensive, and/or are not easy for consumers/people/patients to use.  Some of these efforts will fail.  Some may harm some users. 

Some, though, may show that what we have traditionally done is not enough in the 21st century; just wait until 3D printing becomes cheap and readily accessible. 

Can you hear -- or see -- what's coming?