Objectives

This blog is about the Envoy ESTEEM device that was recently approved by the FDA. By reading this blog you should know how the Envoy ESTEEM device works and how hearing can be improved by this technology.

Moore J. Panel urges FDA to approve hearing device developed in White Bear Lake: The Envoy Medical device uses pacemaker technology to treat hearing loss. Star Tribune (Minneapolis, MN) [serial online]. December 22, 2009:Available from: Newspaper Source Plus, Ipswich, MA. Accessed July 9, 2010.


http://ehis.ebscohost.com.proxy049.nclive.org/ehost/detail?vid=4&hid=114&sid=9b82e418-10e6-4c8f-ae12-bb43419328b3%40sessionmgr111&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d#db=n5h&AN=2W63290776141


This article is not from a professional journal and doesn't provide much information about the Envoy ESTEEM device. It just states that it is to be approved by the FDA and how much funding it had cost to make this type of device a reality for many people.

Barbara M, Manni V, Monini S. Totally implantable middle ear device for rehabilitation of sensorineural hearing loss: preliminary experience with the ESTEEM, Envoy. Acta Oto-Laryngologica [serial online]. April 2009;129(4):429-432. Available from: CINAHL with Full Text, Ipswich, MA. Accessed July 9, 2010.

http://ehis.ebscohost.com.proxy049.nclive.org/ehost/pdfviewer/pdfviewer?vid=6&hid=114&sid=9b82e418-10e6-4c8f-ae12-bb43419328b3%40sessionmgr111


This article goes through the 6 subjects that have received the envoy esteem device. The surgical implantation itself takes a long time, but the results are effective. In 3 subjects a change was seen in their hearing once the device was activated. This device is for moderate to severe sensorineurnal hearing loss and subjects were selected for the trial.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/EarNoseandThroatDevicesPanel/UCM194431.pdf

This is the information from Envoy Medical about the Esteem device that has been posted on the FDA website. It has information about the clinical trials, specific device specifications, and risks. This site goes into great detail about the clinical trials. The FDA would post the information about the science of the trials and the statistics.
This is not such an easy read, it is 42 pages of pure information that is quite an overload for the mind. If you don't have a background or some kind of experience in science you would easily get confused reading this article.

http://www.earcentergreensboro.com/hearing-implants/envoy-esteem-device/index.php

The Ear Center of Greensboro's website provides a lot of great information, not only about the Esteem device itself, but also about what to expect during and after surgery. They inform you of the risks of the surgery and certain things that need to be avoid once implantation has occurred. The site also goes into the science of hearing which allows future patients to truly know how the esteem works.
This site provides a lot of information and is easy to understand. It's sectioned off so you don't have to hunt for information.

http://www.envoymedical.co.uk/

Envoy Medical's website has links to information about its newest hearing device the Esteem. They discuss the differences between normal hearing and Esteem hearing. The site is accompanied by short videos that discuss hearing. The site posted above has a video of an Esteem patient that discusses her experiences with other hearing devices and the Esteem.
This site could have a lot more scientific data. Even consumers need to be aware of the science of how hearing works and why or why not this device is going to work for them. However, the basic information about the device and how it works is presented well and is easy to understand how the device is going to work once it is implanted.