Esteem and Cochlear Implants, What is the Difference?

Hearing implants offer an option for those who have not had success with hearing aids, for various reasons. There is often confusion between cochlear implants and active middle ear implants (AMEI). 

An AMEI refers to a surgically implanted hearing device that directly interacts with a part of the middle ear – one or more of the tiny middle ear bones (i.e., middle ear ossicles) – and is “active” in that it is imparting its own energy on the middle ear rather than just being a passive prosthetic.

The middle ear (see diagram below) - includes the eardrum and three tiny bones (hammer, anvil, and stirrup), which as a connected component comprise the ossicles

Active middle ear implants (AMEIs) can be either fully implanted with nothing external or semi-implanted with an external portion and an internal portion.

They are designed for those who have moderate to severe hearing sensorineural hearing loss and speech understanding better than 40%. Like some other hearing options for those with this type of loss, it requires adequate residual hearing and speech understanding in order to work. 

Esteem is a unique AMEI because it's designed to leverage the natural mechanics of the ear by using the eardrum as a microphone (instead of using an artificial microphone while also being completely implanted.  

The Esteem procedure can be reversed because it's not in the cochlea. If your hearing were to worsen, later on, you can get the Esteem replaced with a cochlear implant quite easily.

Unlike hearing aids, which amplify sound, a cochlear implant bypasses damaged portions of the ear to deliver sound signals to the hearing (auditory) nerve.

Cochlear implants are inner ear implants. typically Indicated for those with severe to profound sensorineural hearing loss and speech understanding less than 40%. If hearing aids are no longer helping you understand or you can hear in only one ear, cochlear implants may help improve your hearing.

The procedure essentially bypasses the cochlea to directly stimulate the auditory nerve and helps the patient hear in an electronic way. Cochlear implants are partially implanted and require the user to wear a sound processor on the outside of their head. The sound processor converts sound into electrical signals transmitted to the implant. and is held onto their head by a magnet. There are stringent guidelines around candidacy for cochlear implants. It can be a lifesaver for the right patient, as they learn to hear in a new way their hearing and understanding can greatly improve.

Inner ear (see diagram above)- the snail-shaped cochlea and the hearing nerve, as well as semicircular canals that help us with balance

Both options offer improved hearing for the right patient! An evaluation with a hearing professional who works with cochlear implants and middle ear implants can help determine what option would be best for your loss.

Envoy Medical was in the news this week, announcing that the FDA approved our Investigational Device Exemption application to begin a clinical trial at Mayo Clinic in Rochester, Minnesota with our first-of-its-kind fully implanted Acclaim® cochlear implant. Learn more here!

The Acclaim is an investigational device and will be in clinical trials for a few years with no guarantee of approval. However,  if it's approved by the Food and Drug Administration (FDA) it may lead to a shift from partially implanted cochlear implants to fully implanted cochlear implants allowing people more usability. 

Would you like to be kept up to date with any significant information on the Acclaim’s approval process and made aware when it becomes available?

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The last two years have been hard on all medical device companies, and unfortunately, we were not spared from the impact of COVID and supply chain issues.

While we can't guarantee a date or predict the future we are continuing towards the fulfillment of the next generation of Esteem. We should have more detail on the timeline by late summer.

Your Help is Needed! The FDA  formally announced the release of their proposed rules for a new category for Over the Counter Hearing Aids (OTC)  last month. The bill is still being finalized but is designed for those with mild to moderate hearing loss enabling easier access and more competition. Those with severe hearing loss or users younger than age 18 would remain as prescription devices.