Advancing Fully Implanted Hearing Systems | By Brent Lucas, CEO of Envoy Medical

Sep 4, 2024 1:57:32 PM

"What do you do for a living?"

"I work for a company that makes hearing implants for people with hearing loss."

"What?"

"I work for …"

"(laughter)"

I have fallen for this joke hundreds, if not thousands, of times. The fact of the matter is that hearing loss is a punchline to most people until they or someone close to them is affected.

After working in the hearing industry for the last 17 years, I can say with confidence that most people take their hearing for granted. We seem to assume our ability to hear will always be there until it begins to deteriorate, and then we struggle to come to terms with the oversized impact hearing loss can have on our lives. As Joni Mitchell famously sang: "You don't know what you've got 'til it's gone."

Hearing loss is common and impacts a large portion of our population. The World Health Organization (WHO) believes that more than 1.5 billion people may have some form of hearing loss during their lifetime, with 430 million of those people having "disabling hearing loss" that requires intervention.[1]

It has been said that "hearing loss is the third most common chronic physical condition in the United States and twice as prevalent as diabetes or cancer."[2] According to the National Institute of Deafness and Other Communication Disorders, approximately 15% of adults - 37.5 million people - in the U.S. ages 18 and older report some trouble hearing.[3] Older Americans have a greater incidence of hearing loss with one estimate suggesting that 68% of people in their 70s and 90% of people 80 or older experience hearing loss.[4]

Unfortunately, hearing loss also tends to be an underdiagnosed or undertreated problem. It is well documented that a majority of people who could benefit from hearing aids have never used them.[5] Even more concerning is the estimate that less than 5% of the adults in the U.S. who could benefit from a cochlear implant choose to get one. Sadly, these low adoptions rates for hearing interventions seem to suggest that we, as a society, are ignoring the fact that untreated hearing loss is closely tied to other health conditions such as social isolation, dementia, balance, risk of falls, and even diabetes and cardiovascular disease.[6]

Envoy Medical: Offering Different Solutions

Traditional hearing devices of one form or another have been available for many decades. Most of these hearing solutions - whether they are OTC hearing aids, prescription hearing aids, bone conduction hearing devices, middle ear implants, or cochlear implants - have some key features in common. First, the traditional hearing devices have an external component that is placed in the ear, on the ear, or behind the ear. Second, they rely on one or more microphones to pick up the sound that the device uses as the signal.

Envoy Medical has taken a different approach with its fully implanted hearing devices, and it looks to turn the industry on its… ear.

We believe that the status quo of traditional hearing devices is not enough for everyone, and our investment thesis is that a large portion of the hearing loss population wants different hearing solutions to choose from.

Envoy Medical currently has two products: the FDA-approved Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI) and the investigational Fully Implanted Acclaim® Cochlear Implant.

Both of our products leverage the actual ear, not microphones, to pick up sound. We operate from the point of view that the human ear is the way it is for many reasons, and that there are likely benefits from leveraging that anatomy. There is no traditional microphone in either of our products. We use the anatomy of the outer and middle ear to pick up sound as you would if you were hearing without any hearing device.

Designed to leverage the natural ear to pick up sound, both of our products are fully implanted with no external components, allowing for several potential benefits. For example, people with our devices can be discrete, if they choose, about their hearing loss and not be forced to share that they are hearing impaired. We believe many people do not treat their hearing loss because they are uncomfortable with the visible nature of existing traditional technologies.

In addition, patients with our devices can leave their devices on all day, every day. Traditional hearing devices such as hearing aids and partially-implanted cochlear implants are taken off at night, for example, leaving the user without hearing during potentially vulnerable times. As a person's hearing loss is with them all day, every day, their device used to treat that hearing loss should be as well.

Hearing Device Coverage Clarification Act

In addition to our two products, we are a strong supporter of the two Hearing Device Coverage Clarification Acts working their way through the House of Representatives and the Senate. Both of these bipartisan bills seek to clarify that fully implanted active middle ear hearing devices should not be classified as hearing aids and therefore not be subject to the Medicare hearing aid coverage exclusion. These devices should be properly classified and considered hearing prosthetics, which would allow Medicare and Medicare beneficiaries access to these important technologies.

Final Thoughts

Hearing is critical to our experience as human beings as it keeps us connected to the world around us. Hearing loss is common and impacts the lives of so many people around us. Unfortunately, as an "invisible disability," it is not given the attention it deserves, and we are paying unnecessary costs as a result.

Envoy Medical is passionate about helping people on their hearing health journey and creating solutions that will positively impact society. We are just getting started and look forward to continuing to innovate in this space.

[1] World report on hearing. Geneva: World Health Organization; 2021. License: CC BY-NC-SA 3.0 IGO.

[2] CDC citing Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for US adults: National Health Interview Survey, 2012. Vital Health Stat 10. 2014; 260:1-161.

[3] https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing

[4] Goman, Adele M. and Lin, Frank R. Prevalence of Hearing Loss by Severity in the United States. American Journal of Public Health. 2016. Found on the internet at

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024365/

[5] https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing

[6] https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-minute-how-untreated-hearing-loss-can-result-in-a-negative-health-spiral

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