Navigation Links
FDA Advisory Panel Votes 15 to 0 in Favor of Approving Envoy Medical's Esteem(R) Fully Implantable Hearing Restoration System
Date:12/21/2009

ST. PAUL, Minn., Dec. 21 /PRNewswire/ -- Envoy Medical, a Minnesota corporation, has developed the first Fully Implantable Hearing Restoration System known as the Esteem®. On December 18th, an Advisory Panel of independent ENT experts unanimously recommended that the FDA approve the Esteem®.

Patrick Spearman, Envoy Medical's Chief Executive Officer, was quoted as saying "This is great news for all sensorineural hearing loss sufferers. Envoy has been able to accomplish with the Esteem® what hearing aids set out to do but were unable to. Our Esteem® allows recipients the opportunity to hear naturally and restore their lives back to normal." In the clinical trial, patients averaged an 11 decibel improvement in Speech Reception Threshold (SRT) scores beyond their hearing aids. At a quiet conversation level, average patient speech understanding improved by more than 45% over their hearing aids.

The Advisory Panel's vote is a recommendation only, and the FDA will still have to formally approve the Esteem®( )before it can be marketed to the public. In most cases, the FDA does follow the Advisory Panel's recommendation.

Esteem® - The Hearing Implant(TM) - is surgically implanted, invisible to others, and once approved for the US market will cost approximately $30,000 (including the device, surgery and audiometric testing).

www.envoymedical.com

SOURCE Envoy Medical


'/>"/>
SOURCE Envoy Medical
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Cell Therapeutics Announces FDAs Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkins Lymphoma, February 10, 2010
2. Favorable Vote from FDA Advisory Committee on Benefit/Risk of CRESTOR(R) (rosuvastatin calcium) in JUPITER Study
3. Advisory Committee Briefing Materials for CRESTOR(R) sNDA Available on US FDA Web Site
4. Asthmatx Receives FDA Advisory Panel Recommendation for Approvable with Conditions for Bronchial Thermoplasty with the Alair(R) System for Severe Asthma
5. CDC Advisory Committee Recommends Cervarix To Prevent Cervical Cancer in Girls and Young Women
6. BrainCells Inc. Broadens Scientific Advisory Board Adding Drs. Edward Scolnick and David Holtzman
7. Cornerstone Pharmaceuticals Adds Acclaimed Cancer Research Pioneer Robert A. Weinberg, Ph.D. to Its Scientific Advisory Board
8. Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)
9. Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
10. FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia
11. FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/21/2017)... Jan. 20, 2017  Faruqi & Faruqi, LLP, a leading ... or the "Company") (NASDAQ: KMPH ) of the ... certain officers and directors and underwriters of the Company,s April ... role of lead plaintiff. The lawsuit has been ... for Johnson County on behalf of ...
(Date:1/20/2017)... , January 20, 2017 Stock-Callers.com ... (NASDAQ: SGYP ), Novo Nordisk A/S (NYSE: ... ), and Pernix Therapeutics Holdings Inc. (NASDAQ: PTX ... on Thursday, January 19 th , 2017, finishing near its ... Care Index dropped over 0.7%, while shares of health care ...
(Date:1/20/2017)... 20, 2017 Entscheidung ... Nothilfe   Die internationale humanitäre Stadt soll um ... schaffen   Seine Hoheit Scheich Muhammad ... sowie Herrscher von Dubai , hat ... Hilfe (International Humanitarian City IHC) zu verdreifachen, um den ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... 20, 2017 , ... Source Vitál Apothecary, a skin and body care company ... the company had a successful visit to the 2017 ECRM Diet, Vitamin & Sports ... work in the nutritional, sports and health industries a chance to meet in private ...
(Date:1/20/2017)... ... 20, 2017 , ... ATP Science, an Australian-based company focused ... the January ECRM Trade Show in Hilton Head, SC, benefiting from outstanding meetings ... of supplements that keep the body functioning at its peak performance by providing ...
(Date:1/20/2017)... York, NY (PRWEB) , ... January 20, 2017 ... ... – VW+ 001 and its sugar-free alternative VW+ 002. The drinks have been ... body with optimal conditions to perform during your workout. , After a successful ...
(Date:1/20/2017)... ... January 20, 2017 , ... “I Forgive You”: a fine examination of how God handles ... the creation of published author, Stephen Miller, who, for over ten long years has been ... him. Born in Trinidad and Tobago, he has been serving the Lord for over twenty ...
(Date:1/20/2017)... ... January 20, 2017 , ... “Knowledge is God’s Lighthouse”: a ... “Knowledge is God’s Lighthouse” is the creation of published author, Gene Gaapf, a retired ... collections. , “I have been writing since high school and have many different ...
Breaking Medicine News(10 mins):