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

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).

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:
(Date:6/26/2016)... VEGAS , June 26, 2016 ... to value-based care operating models within the health care ... enable greater financial efficiency , Deloitte offers a ... the key business issues impacting efficient cost optimization: labor ... , These services facilitate better outcomes and better ...
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
(Date:6/24/2016)... Research and Markets has announced the addition of ... report to their offering. ... The World Market for Companion Diagnostics covers the world market ... the report includes the following: , World ... Region (N. America, EU, ROW), 2015-2020 , World IVD ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand ... project," said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s ... within Final Cut Pro X . Simply select a ProHand generator and drag ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
Breaking Medicine News(10 mins):