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:3/27/2017)... and BOSTON , March 27, ... global pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq: ... and commercialization of innovative therapies based upon tetracycline ... of sarecycline for the treatment of moderate to ... endpoints. Sarecycline is a once-daily, oral, narrow spectrum ...
(Date:3/27/2017)... 27, 2017  PhaseRx, Inc. (NASDAQ: PZRX), a ... liver diseases in children, today reported financial results ... December 31, 2016 and provided an update on ... to make progress during the fourth quarter of ... our non-human primate safety study, and with our lead ...
(Date:3/24/2017)... , Mar 24, 2017 Research ... Therapy Manufacturing Market, 2017-2027" report to their offering. ... The Cell ... the rapidly growing market of cell therapy manufacturing and focuses ... manufacturing facilities. These therapies are anticipated to emerge as viable ...
Breaking Medicine Technology:
(Date:3/27/2017)... ... , ... Harris Communications, Inc., a leading provider of assistive technology for ... Deaf Seniors of America Conference, April 4-7 at the Hotel Westin Galleria in Houston. ... staff from Harris Communications and to try out the newest assistive devices available to ...
(Date:3/25/2017)... ... , ... Getting earned media coverage meaningful for Garden Media Group's clients is ... year, Garden Media aims to provide material helpful to clients’ goals and bottom lines. ... key messages to gain coveted media placements, Garden Media wows clients year-round. , ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... solutions for contaminated soil, dredged material, and hazardous and non-hazardous materials announced today ... Allentown, Pennsylvania. This acquisition will add four additional processing facilities and a ...
(Date:3/24/2017)... ... March 24, 2017 , ... Mediaplanet today ... conversation on the current obstacles facing infection prevention and offer strategies for the ... by these infections. , The print component of “Fighting Infection” is distributed ...
(Date:3/24/2017)... ... March 24, 2017 , ... Digital Scientists, a software innovation lab specializing in ... a Greenville, South Carolina location. The lab has set up shop at ... been working with South Carolina clients for years from our office here in Atlanta,” ...
Breaking Medicine News(10 mins):