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:2/8/2016)... 2016 Aesthetic Devices - Medical Devices Pipeline ... report, "Aesthetic Devices - Medical Devices Pipeline Assessment, 2015" ... stage. This report is prepared using ... by GlobalData,s team of industry experts. *Note: Certain ... based on the availability and relevance of data in ...
(Date:2/8/2016)... 2016  Ventana Medical Systems, Inc. (Ventana), a member ... world,s top oncologists, pathologists, research scientists and healthcare ... annual Tucson Symposium March 8-9 to learn ... outcomes in cancer research and treatments that will ... Thomas Grogan , annually draws more than 500 ...
(Date:2/8/2016)... LEAWOOD, Kan. , Feb. 8, 2016 ... held organization that formerly specialized in the ... facilities, recently announced that it has divided ... Nueterra Capital. While Nueterra Capital will continue ... advisory services, NueHealth will operate a national ...
Breaking Medicine Technology:
(Date:2/9/2016)... (PRWEB) , ... February 09, 2016 , ... Establishment Labs, ... of Dr. David Hung to the company´s Board of Directors. , “We ... class scientist and an exceptional entrepreneur.” said Juan Jose Chacon Quiros, CEO of Establishment ...
(Date:2/9/2016)... ... 09, 2016 , ... ZipHearing.com is proud to ... hearing aids , increase industry transparency, and promote awareness of hearing solutions ... “For the average consumer, the hearing aid industry is esoteric and difficult to ...
(Date:2/9/2016)... ... February 09, 2016 , ... Sir Grout, ... , is proud to announce that many of their franchises have received the ... The hard surface restoration franchises received customer recognition through positive reviews and testimonials, ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... its newly redesigned website, federallabs.org . The site houses a wealth of ... available federal technologies through the process called technology transfer (T2). As a network ...
(Date:2/8/2016)... ... ... man who has struggled to quit smoking, a man who has struggled with hair loss ... to his problems – and he did. Now Nabat, a serial entrepreneur featured as the ... inventions to the world and better people's lives. His own experience with nicotine addiction led ...
Breaking Medicine News(10 mins):