The White House Briefing Room this week said a new executive order aimed at promoting competition in the American economy was issued. In the order, the President directs HHS “to consider issuing proposed rules” for over-the-counter (OTC) hearing aids “within 120 days”.
OTC hearing aids were among 72 initiatives, the executive order includes mandates to lower prescription drug prices, ban and limit non-compete agreements and occupational licensing requirements, ban excessive early termination fees for internet service, and make it easier to switch banks. .
The Biden administration argues that “fewer large players have controlled more of the market” in areas like “prescription drugs, hearing aids, and internet service”. The administration also predicts that OTC hearing aids will “save Americans with hearing loss thousands of dollars by allowing hearing aids to be sold over the counter at drug stores”.
Regulating OTC hearing aids
Surprisingly, many DTC hearing aids are registered with the FDA under product classifications that are intended for medical-model hearing aids. If the FDA forces DTC sellers to reclassify their products as OTC (once the new class exists) and requires product clearance (510k), this would mean that many of the FDA-registered hearing aids being sold DTC today may be pulled from the market temporarily.
This would ultimately be a good thing for consumers. It would mean that consumers would receive an enhanced level of protection from the FDA, as manufacturers would be required to prove the effectiveness and safety of any devices being sold directly to consumers. Without audiologists vetting the products by fitting them on their patients, the FDA has a higher level of responsibility to vet the products before allowing them to be sold on the open market. (My personal opinion)
The Office of Management and Budget (OMB) recently published its official Spring 2021 Unified Agenda, which included tentative plans for the FDA to address OTC hearing aids in 2021. This isn’t the first time the FDA has planned to work on the rules—this is the fifth time the rulemaking session has been scheduled—but today’s announcement does seem to indicate that there is a higher likelihood of the session actually occurring.
Kate Carr, Hearing Industries Association (HIA) President, said “once the draft is released, we anticipate a public comment period, followed by further FDA review. It could take up to nine months or more for the final regulation to be released.” She also shared the following graphic, which helps illustrate FDA’s rulemaking timeline:
FDA Rulemaking Timeline, courtesy HIA
Hearing aid stocks dropped on the news
The share price for the largest medical-model hearing aid manufacturer on the planet, Sonova, was down sharply (~7%) following the announcement. Other large players were down too: Demant A/S was down ~9%, and GN was down ~6%. Eargo’s stock was also down.
The Noopl helps people hear more clearly in background noise. The $199 device clips onto the bottom of an iPhone and utilizes a three-mic array and beam steering to help focus in on speech more clearly. By using the head tracking technology built into the Airpods Pro, it is designed to detect which direction the user is facing to help better reduce background noise and enhance speech.
Dr. Trine is a hearing industry veteran. Prior to joining Noopl, he spent 19 years with Starkey Hearing Technologies in Minnesota before moving to San Francisco in 2017 to be Chief Technology Officer for direct-to-consumer hearing aid maker, Eargo. He holds a Ph.D. in hearing science from the University of Minnesota, an M.B.A. from Northwestern University, a master’s degree in Audiology from Vanderbilt University, and his bachelor’s degree in communication disorders from California State University, Northridge.
According to Dr. Trine, the microphone array processing technology in the Noopl 1.0 accessory was developed over 5 years through a collaboration between the renowned National Acoustic Laboratories (NAL), the HEARing CRC, University of Melbourne and Noopl, Inc.
The company has also recently partnered with Chatable to continuously improve its speech processing abilities. Chatable helps users focus on in-person conversation by “providing clear voice without noise, using an AI-based approach to noise reduction by leveraging real-time neural speech synthesis”. Combining the Noopl device and iOS app with Chatable technology aims to deliver an even better product for users to hear through the noise.
Who Can Benefit from Noopl?
The Noopl device is intended to be used for situational hearing challenges – specifically, trouble hearing clearly in background noise.
While trouble hearing in background noise often the biggest complaint among people with hearing loss in general, there are also millions of individuals with so-called ‘hidden hearing loss‘, who could potentially benefit from this type of technology.
Our test device arrived in nice clean packaging, which included: Noopl 1.0 device, multiple couplers, carrying case and an easy to follow Setup Guide.
The device, which is compatible with iPhone 7 and newer models, is very lightweight and plugs directly into the bottom of the iPhone through the lightning port.
One of the critical parts of setting up the Noopl device on the iPhone is to ensure you have the appropriate coupler – which will vary based on the model of iPhone and whether or not it has a cover. Fit incorrectly, performance will suffer and could result in feedback.
Downloading and setting up the iOS app with the AirPods Pro was found to be very simple and straightforward.
The app is easy and intuitive to use. Adjustable volume and noise reduction levels allow the user to adjust and customize the incoming sound.
The most impressive feature, however, is the steerable beamformer.
Head steering information from the AirPods Pro® is passed through the iPhone to the Noopl 1.0 accessory to steer the directional array based on the direction the user is looking every few milliseconds–which is displayed visually as the user turns their head. In addition, the app is designed to automatically recognize whether the user is holding the phone or has their phone on a table and optimizes the directional performance accordingly.
The device can also be manually controlled to alter the focus of the microphone towards whichever speaker or sound source you want to hear.
We found this feature to work as advertised, both in the automatic and manual modes, using the AirPods Pro.
Does Noopl Only Work with AirPods Pro? What About Hearing Aids?
“We chose AirPods Pro because they currently have the lowest latency Bluetooth audio connection. We will be qualifying other TWS earbuds but currently the only earbuds that currently support a low-latency connection are the AirPods and the PowerBeats Pro,” said Dr. Trine. “I anticipate that this will change rapidly as both cell phone and earbud manufacturers begin to support the Bluetooth 5.2 standard.”
We asked Dr. Trine if Noopl plans to offer compatibility with wireless hearing aids and cochlear implants in the future.“We already work with all MFi hearing aids and cochlear implants! In fact, some of our most delighted customers are cochlear implant users who for the first time in their lives are able to communicate in a noisy environment. It’s amazing to hear their stories. The key to success for both hearing and and cochlear implants users is to ensure that their ear-level microphone input is muted when using Noopl. Doing so ensures that the signal to noise ratio advantage offered by the Noopl processing is maintained.”
The Noopl device also supports other wireless earbuds, as well as MFi hearing aids and cochlear implants. However, the automatic steering feature is currently only available on the AirPods Pro.
Noopl offers users a simple, affordable solution to address a common problem – hearing clearly in background noise.
While it’s currently limited to iPhone users, the device holds a great deal of promise for millions people with hearing loss and those who experience situational hearing problems in background noise.
The company tells HHTM that it expects to begin supporting Android phones by winter 2021. For more details visit Noopl’s website to learn more.
A conversation with Jacob Skinner, Ph.D., CEO, Thrive Wearables
Hearables, in-ear devices that use sensors to monitor health, are on the brink of becoming the next revolutionary technology. While in-ear devices have been around for decades in various iterations (used primarily for transmitting sound), the application of this technology in the medical field is a relatively new area to explore. Jacob Skinner, CEO of U.K.-based wearable technology design and development consultants Thrive Wearables, discusses its possibilities.
Why Are Hearables Becoming More Important As A Technology Now?
Skinner: In recent times, sensor technology has shrunk significantly so that all kinds of capabilities can be added to in-ear devices, creating a subcategory of wearable technology that we call hearables. Additionally, most of us carry a supercomputer around in our pockets, which can process data sent to, and received from, in-ear sensors.
Technology for transferring information is getting better, too. Early Bluetooth headphones traded audio quality for convenience, but today’s wireless earphones are good enough for all but the most dedicated audiophile. Last year, a new standard, Bluetooth LE Audio, was announced that can support hearing aids, streaming to multiple devices, and the Low Complexity Communications Codec (LC3, which transmits at lower bit rates, meaning that the device can use less power and can be less bulky).
In addition, almost all of us use earphones of some kind, whether they are wireless, Bluetooth-connected, in-ear buds, or wired headphones that go over the ear. We’re all pretty comfortable with the technology, which helps with patient adherence of this burgeoning field. So, the reason hearables are growing now is a combination of a form factor that we’re all used to and improvements in technology that enable us to make earphones do more than ever. It’s common for wireless earbuds to have a microphone, for example, and a sensor that stops playback when an earphone is removed from the ear. But we are now seeing them become health and fitness devices.
What Can Hearables Bring To The Health And Wellness Space?
Skinner: Some of this technology will simply offer an improved listening experience, based on individual circumstances, and some products are merging traditional ear device uses (listening to music or phone calls) with medical uses. EVEN’s headphones and Nuheara’s IQbuds, for example, both adapt their output to boost frequencies the listener doesn’t hear so well. Everyone’s hearing is slightly different, so compensating for personal limitations or age-related hearing loss can help.
Other technologies use earphones to monitor activity, stress, and even the brain. Sensors can be used for photoplethysmography (PPG), which is the use of light to detect changes in blood volume. That can tell you things like oxygen saturation (SpO2), blood pressure, and pulse rate. Blood pressure is a good measure of overall health, while SpO2 can monitor lung conditions, sleep apnea, and patients with cardiac conditions, among other things. Analyzing changes in this data could provide early indication of heart or blood pressure problems, as well as things like stress or drowsiness.
We can measure heart rate variability, too, which is the time difference between heart beats. A heartbeat of 60 beats per minute is not literally one beat every second. The gaps between beats will vary and the greater the variability, the better condition you are in. Using an in-ear sensor to measure this can help track overall fitness or recovery from a heart procedure.
Another way to monitor heart activity is with electrocardiography (ECG) sensors, which track electrical impulses, while electrodermal activity (EDA) sensors can be used to analyze breathing patterns. Electroencephalography (EEG) sensors, like those in the Kokoon sleep headphones, use electrical signals to monitor brain activity; Kokoon uses the information from its sensors to play white noise for those with trouble sleeping (Kokoon recently won a Red Dot Award in the Product Design category from Red Dot GmbH & Co. KG). Brain monitoring is developing rapidly and could be used to monitor stress, epilepsy, or even complex mental illnesses.
These are far from the only options. Temperature, motion, and other metrics can all be gathered from hearables. Electrical signals can track eye movement, which offers a way to monitor attention and alertness. Measuring changes in the shape of a user’s ear canal can identify facial expressions, which could become a means for controlling these devices or play a role in mood tracking.
What Can We Learn From That Data?
Skinner: Hearables can be useful for telling us what is happening in the body right now. They could tell you whether you are within the correct heart rate range for your exercise plan, for instance, and use an audible signal to tell you to speed up or slow down.
But trend data can be even more useful. Once a system begins to understand what is normal for your body, it can use anomalies to detect potential health problems. Combining several measures, along with things like voice recognition and head movement, could be a powerful indicator of overall health and well-being. Abnormal data could trigger anything from recommended deep breathing exercises for stress relief to scheduling an appointment with a clinician based on emerging cardiac symptoms.
When many people use these devices, their data can be analyzed in aggregate – with appropriate privacy controls. That would allow artificial intelligence and analytics to look for patterns and draw conclusions beyond those that can be derived from individual data. We might identify new warning signs of heart disease, for example, based on data collected from millions of people before they showed any symptoms.
Many of these applications are some time away from being reliable and widely used, but the pace of innovation is fast and increasing. We are just a few years away from widespread consumer use of hearables for health monitoring, but specific, niche medical uses are already happening.
Why Are Hearables Ideal For Data Collection Rather Than Wrist-Based Wearables, And What Are The Technological Challenges?
Skinner: Wearable tech for health and wellness has so far focused on wrist-based devices. However, signals from the ear are as much as 100-times clearer than those from the wrist. The inside of the ear is dark, closer to the body’s core, and the arteries are nearer the surface of the skin, which makes heart rate monitoring easier.
On the wrist, in contrast, sensors must work around muscles and tendons. During exercise, people tend to move their wrists a lot, while their heads stay relatively stable. Wrist-based monitors shine a light into the skin to detect blood flow, but if the device isn’t fitted snugly to the wrist, light can get in and reduce the effectiveness of the sensor. And unlike the inner ear, the wrist gets sweaty, which can make it hard for sensors to capture a good signal, resulting in variable quality insights.
The ear is also a good location for monitoring signals from the brain and eyes, and is less obtrusive than brain-computer interfaces that must be worn on the head. Speech recognition is easily handled by a microphone on an earpiece, and head movement is easily tracked, too.
The challenge with a device that you wear in your ear is that it has to be small and light, which obviously restricts how many sensors you can pack in. The sensors have to be small and there has to be room for a battery to power them. For a consumer device, you need to fit in speakers and a microphone, too. It’s a design challenge to make something that is comfortable to wear, with a practical battery life and the features that provide value. However, since the pioneering work of the German startup Bragi, a lot of investment has gone into creating new technologies that are specifically designed to work at ultra-low power and in extremely constrained form factors. There is also historical work in the hearing aid space, and this level of advancement has meant that hearable technology is able to move at significant pace. With this backdrop, and due to the consumer pull and market validation of AirPods, new sensors and advanced technologies are finding their way into our ear-worn wearables. These factors somewhat mitigate the challenges we face in product development.
What Does The Future Look Like?
Skinner: The industry will see a boom in hearables. The COVID-19 pandemic slowed things down somewhat. Hearable shipments grew by 258 percent in 2019 but only 37 percent last year, mostly because of supply chain disruption during lockdown. However, we will see growth increase again because of the amount of innovation in the sector. The market is still expected to be worth $146 billion by the end of the decade.
Consumer devices are going to continue to add more features, with many of them becoming alternatives to hearing aids for the hundreds of millions of people with disabling hearing loss. Health and fitness remains a natural area for growth, too, because so many people like to wear earphones while exercising and they are naturally interested in their overall wellness. We are also likely to see these devices integrate with augmented reality (AR) and virtual reality (VR) use cases — particularly in creating “surround sound” effects and greater personal assistant capabilities.
More specialized use cases have fascinating possibilities. We can monitor recovery from heart procedures more effectively than ever before, for example, and we are just beginning to look into the possibilities for mental health.
This year is an especially pivotal year for ear-based technology. Through my work at Thrive, I am seeing innovators in this space, and the products coming along are very exciting. It’s clear that hearables represent a fantastic opportunity to measure high-fidelity signals and turn these into a new generation of ultra-sensitive and accurate health technologies.