First and Only: Fully Implanted Esteem® Hearing Device Receives FDA Approval for MR-Conditional Labeling at Both 1.5 and 3.0 Tesla
WHITE BEAR LAKE, Minn.--(BUSINESS WIRE)--Aug 7, 2018--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 year 1.
“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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CONTACT: Envoy Medical Media Inquiries
Jennifer Maleitzke, 651-361-8030
KEYWORD: UNITED STATES NORTH AMERICA MINNESOTA
INDUSTRY KEYWORD: SURGERY TECHNOLOGY CONSUMER ELECTRONICS HARDWARE AUDIO/VIDEO HEALTH MEDICAL DEVICES RADIOLOGY MANUFACTURING ENGINEERING RESEARCH FDA SCIENCE
SOURCE: Envoy Medical Corporation
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PUB: 08/07/2018 12:54 PM/DISC: 08/07/2018 12:53 PM