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:5/4/2017)... May 4, 2017  DarioHealth Corp. (NASDAQ: DRIO), a ... big data solutions, today announced that it is teaming ... STI Technologies Limited to lower diabetes healthcare costs in ... innoviCares card, which is available throughout all provinces and ... will be eligible for additional savings when shopping for ...
(Date:5/4/2017)... , May 4, 2017   BioLife Solutions ... developer, manufacturer and marketer of proprietary clinical grade ... ("BioLife" or the "Company"), today announced that the Company,s ... market close on Thursday, May 11, 2017, and that ... webcast at 1:30 p.m. PT that afternoon. Management will ...
(Date:5/3/2017)...  Kalorama Information notes that transplant diagnostics is ... and this is projected to continue to 2021. ... or bone marrow transplants require histocompatibility between the ... this task. This according to a new report ... various PCR-based methodologies, Sanger sequencing and NGS used ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... 24, 2017 , ... Patients who want to receive cosmetic dentistry procedures such ... Joseph Bedich for a consultation, with or without a referral. Dr. Bedich enjoys improving ... , Dr. Bedich offers a variety of cosmetic dentistry services at his ...
(Date:5/24/2017)... ... May 24, 2017 , ... Medic CE , a ... Truth about Pediatric Septic Shock” hosted by the Journal of Emergency Medical Services (JEMS). ... Eastern time, will be presented by Captain Rommie Duckworth, LP, a career fire captain ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... and nonprofit hospitals and health systems in the nation and help their organizations ... led professional organizations and been instrumental in developing successful hospital and health system ...
(Date:5/23/2017)... SANTA CLARA, CA (PRWEB) , ... May 23, 2017 , ... ... government and financial organizations, today announced CIO Applications magazine has named the company a ... of its innovative use of the Cloud to help organizations simply and proactively address ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... a 2017 Best in KLAS category winner, has named Daniel P. Bullington as ... and enhance its technology platform and product offerings,” says Justin Neece, president. “Daniel ...
Breaking Medicine News(10 mins):