Market Overview

First and Only: Fully Implanted Esteem® Hearing Device Receives FDA Approval for MR-Conditional Labeling at Both 1.5 and 3.0 Tesla

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Envoy Medical Corporation has announced U.S. Food and Drug
Administration (FDA) approval for magnetic resonance (MR)-conditional
labeling for the Esteem® Hearing Implant, the first and only
active middle ear implant to receive approval for MR-conditional
labeling in both 1.5 and 3.0 Tesla (T) scanning environments.

MRI continues to be one of the most important imaging tools available
for healthcare professionals to diagnose and monitor a wide range of
health issues. Its use is prevalent across many areas of medicine as it
is particularly useful in imaging soft tissues such as muscles,
ligaments, nerves, the spinal cord, and the brain. In addition, certain
interventional procedures use MRI to guide the physician during the
case. In the United States alone, it is estimated that many millions of
MRI scans are completed every year1.

"MRI scans are widely used and seen as a preferred imaging tool across a
variety of situations," said Brent Lucas, Envoy Medical's Chief
Executive Officer. "We did not want people to have to make a choice
between our device and the chance that they will need an MRI in the
future. MR-conditional approval at both 1.5 and 3.0 Tesla gives Esteem®
patients the peace of mind that they can safely undergo certain MRIs
without having to endure the additional surgeries, hassles, and costs to
have the device partially or fully removed beforehand."

Surgeons and audiologists who work closely with hearing implants are
often asked about a device's compatibility with MRI. It has been seen as
a limitation of middle ear implants that all of them were
contra-indicated for "high-resolution" 3.0 T scans, and all but one were
also contra-indicated for 1.5 T.

"MRI is one of the most useful and powerful diagnostic tools in modern
medicine," noted Dr. Jack Shohet, MD, of Shohet Ear Associates Medical
Group in Orange County, California, "MRI compatibility is an important
consideration when thinking about any implanted hearing solution. The
news about the Esteem® – that we now have a middle ear
implant that can be safely scanned at both 1.5 and 3.0 Tesla –
represents a significant advancement in middle ear implant technology
and its applicability to a broader group of patients."

Patient safety during MRI scans is clearly the most important
consideration when talking about whether an implantable medical device
can undergo an MRI scan. Another important concern is the quality of the
resulting image and how much distortion or "artifact" was created by the
implanted medical device being present in the body.

"Most other implanted hearing devices contain magnets for one purpose or
another. Some have a magnet that directly interacts with the middle ear
bones while others have a magnet under the scalp to hold an external
sound processor in place," said Paul Mazanec, Envoy Medical's Chief
Technology Officer. "The Esteem® does not contain any
implanted magnets, which obviously reduces safety and comfort risks
associated with magnetic coupling during MRI, but it also helps minimize
the amount of image distortion around the implant. It is one thing to be
able to get an MRI with an implant, that's obviously great, but it is
even better to know that the implant you have causes less image
distortion and artifact than other devices around the implant itself,
especially if you need an MRI of the head or neck," said Mazanec.

About the Esteem® Hearing Implant
The
best way to understand the Esteem® is to first understand
what the Esteem® is not. It is not a hearing
aid, cochlear implant, or device for conductive hearing loss. It is
not
external, in the ear canal, or partially-implanted. It does
not
use a microphone to pick up sound. It does not use a
speaker. It is unlike anything else on the market.

The Esteem® is a fully-implanted active middle ear implant
designed to alleviate moderate to severe sensorineural hearing loss in
adults. It uses the natural ear to pick-up sounds, bypasses a portion of
the middle ear, and then directly drives the inner ear. It is a hearing
loss solution for those who do not get enough from their hearing aid or
who do not wear their hearing aid because of limitations.

The Esteem® is the only one of its kind and it has regulatory
approval in the US and several other countries.

NOTE: Federal Law restricts this device to sale by or on the order of a
physician. The practitioners who may implant this device require
specific training. For additional information on the indications,
contraindications and safety information regarding the Esteem, please go
to the Important Safety Information link at https://esteemhearing.com/important-safety-information/

About Envoy Medical Corporation
Envoy Medical Corporation (https://esteemhearing.com/),
headquartered in Minnesota, seeks to help people live better, more
fulfilling lives through principled innovation in medical devices. Envoy
is the global leader in fully implanted hearing devices that alleviate
hearing loss in a way that allows all-day, every-day hearing in nearly
any situation.

1 OECD (2018), Magnetic resonance imaging (MRI) exams
(indicator). doi: 10.1787/1d89353f-en (Accessed on 01 August 2018)

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