Q&A: Advancing digital technology to address hearing loss

Jul 19, 2024 8:14:00 AM

What are the main challenges that healthcare faces in relation to improving hearing and how can digital technology help?

To gain an understanding of the sector from the perspective of an innovative firm, Digital Journal spoke with Brent Lucas, Chief Executive Officer of Envoy Medical Corporation.

Lucas has over 15 years of experience in active implantables in the hearing health industry. He has served in various roles and gained a tremendous amount of specialized experience, working his way up from an intern to CEO. Mr. Lucas received his Bachelor's Degree from the University of St. Thomas and JD from the Mitchell Hamline School of Law.

Digital Journal: Can you provide a brief background on Envoy Medical?

Brent Lucas: Envoy Medical (Nasdaq: COCH) is a leading medical device company providing innovative technologies across the hearing loss spectrum that improve outcomes for patients. We have two surgically implanted, fully internal hearing devices. One of our devices, the Esteem®, is an FDA-approved fully implanted active middle ear implant, and our newest device, the Acclaim®, is a fully implanted cochlear implant that received Breakthrough Device Designation from the FDA and is currently in clinical trials. Both products use our sensor technology to pick up sound vibrations coming in through the ear rather than using an external or internal microphone. We believe we are well-positioned to become one of the leading companies in the hearing implant market, and have a opportunity to create substantial value for our investors as we disrupt the existing market. We are owned and operated, including manufacturing, in the United States.

DJ: How does hearing work and what can people to do to protect their hearing?

Lucas: Hearing begins with sound waves reaching the outer ear. The outer ear's shape helps us localize where sounds are coming from, focus on human speech, and filter out some distracting background noise. The sound waves are then funneled down the ear canal to the ear drum. Once those sound waves hit the ear drum, it vibrates and engages three tiny hearing bones called the ossicles. Those three bones carry the vibrations to the cochlea where the mechanical energy from the vibrating bones pushes on fluid-filled cochlea. Inside the cochlea there are tiny hair cells that move as a result of the cochlea fluid moving. As the hair cells move, it causes a signal to be sent to the brain via the hearing nerve. The brain does the heavy lifting of interpreting what those signals mean and giving us the perception of hearing.

Most hearing loss is the result of those tiny hair cells in the cochlea being damaged over time. Not all hearing loss is the same and some is the result of genetics, aging, and certain illnesses, but you can increase your odds of not experiencing hearing loss by not being exposed to loud noises for long periods of time, wearing ear protection when in loud environments, and making sure you avoid ototoxic medications like aminoglycoside antibiotics, salicylate pain relievers, and others. Everyone should be careful how loud they listen to things and pay attention to how loud the volume is when using things like headphones or ear buds.

DJ: What are your key products and what makes them different from others on the market?

Lucas: We currently have two products. The Esteem® is an FDA-approved fully implanted active middle ear implant and the Acclaim® is a fully implanted cochlear implant that is currently in clinical trials. Both of our devices are surgically implanted and fully internal, without bulky external components and nothing on the side of the head or inside the ear. Our products also do not rely on microphones to pick up sound, because we leverage the natural anatomy of ear by picking up the sound vibrations off of the middle ear ossicles (the three tiny bones on the other side of the ear drum). All other hearing implants commercially available and in development rely on a microphone and all other hearing implants on the market (approved for commercial use) have external components on the side of the head, which many patients can find annoying or cumbersome.

Due to our products being fully internal, they can remain on all day and in more situations. Devices with external components need to be taken off at night, in the shower, and during some activities where they can be damaged. Our products are fully internal and allow patients to access sound 24/7, without having to worry about the external device getting in the way.

DJ: How have advances in digital technology aided the development of your products?

Lucas: Our devices are sophisticated medical devices. Digital technology is critical to the development of these devices from a concept on the back of a napkin to an actual device that can be implanted in a human being. In addition to our fully implanted devices, we have programming software and patient remotes that can be used to adjust settings of the device. None of this would have been possible without sophisticated digital technology aiding our engineering team in their development.

DJ: What is the Hearing Device Coverage Clarification Act and where does it currently stand?

Lucas: The Hearing Device Coverage Clarification Act is a bi-partisan bill that was introduced in the House of Representatives by Representatives Michelle Fischbach and Angie Craig. The purpose of the bill is to clarify that fully implanted active middle ear implants - like our Esteem® and others - are not hearing aids and should not be treated like hearing aids by Medicare and Medicaid. Hearing Aids are not coverable benefits under both insurance programs. The Esteem® has been improperly classified as a hearing aid by individuals at Centers for Medicare and Medicaid Services (CMS) for years, which has effectively denied access to this breakthrough technology for many patients who may have benefited from a fully implanted device. The Bill, should it become law, would correct this classification and allow patients who cannot afford the device and procedure without insurance to get access to fully implanted active middle ear implants.

The bill is currently gaining co-sponsors in the House and there is support to get a companion bill introduced in the Senate. From there, it will need to find its way onto a piece of legislation that is voted on in both houses to become law. Government is hard to predict, but I am optimistic with how supportive so many legislative offices have been in both the House and the Senate that this bill will pass in the near future.

DJ: What changes do you expect in the hearing health industry in the next five years?

Lucas: I believe that there will be some significant changes in the hearing healthy industry lead by Envoy Medical. Namely, I believe that you will see a fully implanted cochlear implant from Envoy Medical continue to progress through its clinical program and work toward approval. Approval of the Acclaim® will be a monumental shift in the hearing implant space, allowing millions to leave behind bulky hearing aids and use their ear more naturally with fully implanted devices.

Hopefully, we will also see the Hearing Device Coverage Clarification Act work its way through Congress to become law. If that happens, you will see a major increase in innovation and competition within the hearing implant space. This will ultimately result in more options for patients, better hearing healthcare, and better quality of life for those suffering from hearing loss.

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