Invisible Hearing-Aid Implant Developer Envoy Medical Will Answer $140 Million Question This Year

Envoy Medical Esteem Implant

The Envoy Medical Esteem Implant Picks Up Sound Waves In The Middle Ear, Conditions Them With A Processor Implanted Behind The Ear, And Drives Amplified Sound Back Through The Middle Ear

Envoy Medical’s Esteem hearing-aid implant is a revolutionary new approach to hearing restoration. Completely unlike any other hearing aid or cochlear implant on the market, it provides significant functional and cosmetic benefits: no device is required for the outer ear, so sound is not obstructed as it passes through the ear canal; there is no artificial amplification of sounds before they reach the ear drum, which means sound is processed naturally through the outer ear; and the implanted system is completely invisible.

FDA approval of the patented system in 2010 cheered Envoy Medical’s all-star cast of investors, who so far have anted up $140 million in capital. But now it’s time to answer the big question, which is whether the Esteem invisible hearing aid will correct damaged hearing any better than the latest generation of less expensive and less invasive digital hearing aids. At a reported cost of $30,000, the implant is five-to-ten times the cost of today’s highest-end in-ear digital hearing aids, so the Envoy’s Esteem hearing system will have to prove it’s got a superior value proposition as it makes its way into the marketplace in 2011.

The Envoy Medical Esteem implant eliminates the need for a microphone or speaker by implanting a sensor in the middle ear that captures sound waves flowing naturally through the outer ear and eardrum and to the incus, one of the small bones in the middle ear that transmit sound to the cochlear hearing nerves in the inner ear. A digital sound processor implanted in the skull behind the ear receives and conditions the signals, returning them to a driver in the middle ear that stimulates the spur-shaped stapes bone to deliver properly amplified signals into the cochlea. The company’s excellent video animation shows how the system works.

According to the company, initial performance results are impressive. In an Envoy Medical video, Dr. Michael Glasscock, an ear surgeon who was among the first to have the Esteem system implanted behind both ears, says clinical studies of early users resulted in a 45 percent improvement in word recognition over their experience with regular hearing ads. As the Esteem implant finds a broader market in 2011, it should start to become clear how well those initial strong results hold up, and how broad a range of patients’ needs the implant will serve.

In the meantime, Envoy Medical seems poised to take its place among other major suppliers of hearing implant systems, including cochlear implant makers Cochlear Ltd. and Advanced Bionics. As with any invasive medical procedure, there are risks to auditory implants. Cochlear implants have experienced quality and performance issues over the years. But unlike cochlear implants, which thread a tiny filament through the cochlea in the inner ear, the Envoy Medical system only engages the middle ear, which is more familiar territory for ear surgeons.

One of Envoy Medical’s all-star investors — Starkey Laboratories of Minnesota, one of the world’s six largest hearing-aid suppliers — provides a measure of how seriously makers of traditional hearing aids are taking the new hearing implant technologies by investing in them. 2011 will give an indication of how necessary it will be for those hearing aid makers to hedge their bets.

Comments

  1. David Howel says

    I cannot pass a hearing exam for employment without hearing aids, I need help. Are these implants water proof and what is the power source for continued operations, what is the warranty?

  2. Sarah says

    I have bilateral hearing loss, severe in both ears. Even the most expensive hearing aids on the market only offer partial help to me. Insurance does not cover the cost of hearing aids. $30,000 would put these completely out of my reach…

  3. Sandy says

    My hearing loss is having a detrimental impact on my job and my family life. So much so that after spending $4K on the top of the line hearing aids, I was researching implants as an option. However, Esteem implants ,at their current cost for even one ear, is just not an option for me.

  4. Sonia Mesler says

    I am on SS income, I could not find the cost of the implant, too costly that do not want to list the cost?

  5. Chip says

    It appears from the website that those with Meniere’s will be excluded from using this device. This is disappointing. Is this just during the trials?

  6. Lance says

    Mandy,

    How much of a hearing loss did you have? Also, is this permant, if I got this and it really doesn’t help me coul dht operation be reversed so I could wear hearing aids again? I’m curious if this is for the profound deaf like me. I am currently trailing a new digital hearing aid and so far (after 30 days) I dont like it, it’s not loud enough and I can’t hear my own whistle when I could with my analogue hearing aids (it might need further adjustments though.
    Lance

  7. Mandy says

    The battery replacement involves a simple outpatient procedure in your doctor’s office, in which a small incision is made to remove and replace the processor. I’ve only had my implant since June of 2008, so I haven’t yet needed a battery replacement, but my sister had hers replaced.

    The eight week period of no hearing after the initial surgery (not the battery replacement, which will be activated immediately) was difficult at times, but manageable.

  8. GL says

    Hi,

    Did you ever check out the Otologics system?

    They claim that Otologics does not ruin your hearing unlike the Esteem product which does.
    The Esteem product requires the ossicular chain to be disarticulated (surgically separated). The tip of the Sensor and Driver extend into the middle ear. The surgeon connects the Sensor and Driver to your incus and stapes, respectively. The Sound Processor is implanted behind the ear, under the scalp. Insulated wires connect the Sound Processor to the Sensor and Driver.

    For approximatley six to eight weeks after surgery, you will not be able to hear through the ear in which Esteem® is implanted. This is due to the fact that your Esteem® will not yet be activated. Your physician will determine when Esteem® can be “turned-on” or activated. (read here http://www.envoymedical.com/esteemr-implant-procedure for more info).

    The Otologics does not separate anything.

    In fact, this means that with the Otologics you’ll hear after the operation just as before but after 8 weeks you’ll hear via the Otologics, even if your otologics will be switched off you’ll continue to hear as before the operation.

    With the Esteem you’ll need the device switched on, else you’ll hear nothing, even with your hearing aids. (They can reverse the operation with the Esteem Device with a synthetic ossicular chain.)

    Please let me know your thoughts.

    GL

  9. David Copithorne says

    GREAT question about the battery, and I should have looked more carefully. Here is what Envoy Medical says in its filing with the FDA:

    “The Esteem is powered with a maintenance-free battery that requires no
    recharging. The long-lasting lithium-iodide battery has a long history of reliable use in the implantable cardiac pacemaker industry. Typical usage of the Esteem will result in an average useful life of over 6 years. Battery replacement is done by surgically replacing the Sound Processor.”

    I guess having to go back in and replace the battery every six years is a bit of a gotcha — but maybe if you are brave enough to go ahead and get an implant in the first place, the second time around is less scary. The battery is in the processor implanted in the skull bone behind the ear, so I assume it’s a less-invasive procedure than if you had to go back into the middle ear.

  10. Lance says

    I’m curious how this thing will be powered since it’s in the head and there are no outer components how will this thing get it’s power? Will there be an awesome transforming hair that slides out a batery compartment when you pull your ear? :) JK but seriously… what powers it?

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