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.