Navigation Links
FDA Approves First Totally Implanted Hearing System
Date:3/17/2010

Esteem approved to treat sensorineural hearing loss

SILVER SPRING, Md., March 17 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced the approval of the Esteem – an implanted hearing system used to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss.

(Logo:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Sensorineural hearing loss is usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections, or aging. The results are reductions in perception of sounds and in the ability to understand speech.

This differs from conductive hearing loss, which occurs when sound waves cannot transmit well through the outer or middle ear or both. Medical or surgical treatment can often restore hearing in people with a conductive hearing loss, which can be caused by earwax, fluid in the middle ear space, or a punctured eardrum.

The Esteem system consists of external testing and programming instruments and three implantable components: a sound processor, sensor, and driver. The sensor senses vibrations from the eardrum and middle ear bones and converts these mechanical vibrations into electrical signals, which are then sent to the sound processor, which amplifies and filters the signal to compensate for the individual patient's hearing loss. The driver converts the enhanced electrical signal back to vibrations, which are then transmitted into the inner ear where they are perceived as sound.

"The approval of Esteem provides patients with an option to alleviate their hearing loss by using a device with no readily visible external components," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

The system is designed to alleviate the effects of hearing loss in patients ages 18 years and older. Other criteria for the device include: stable bilateral sensorineural hearing loss, a normally functioning Eustachian tube, and normal middle ear anatomy. A patient's ability to understand speech using Esteem should be similar to that of conventional hearing aids.

In a multicenter clinical study of Esteem versus pre-implant hearing aids, 93 percent of Esteem recipients scored equal to or better than their pre-implant hearing aids on a speech intelligibility test. Seven percent scored less than with their pre-implant hearing aids, and 56 percent scored better than with their pre-implant hearing aids.

Seven percent of participants experienced facial paralysis, and 42 percent experienced taste disturbance, both of which are results of the surgical procedure necessary to implant the device. The majority of these adverse events resolved during the one-year study period.

As a condition of FDA approval, Esteem manufacturer, Envoy Medical Corporation of St. Paul, Minn., must conduct two post-approval studies. In one study, Envoy must continue to follow-up on 61 subjects from the original study for five years to study safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation, and evaluate the effectiveness of Esteem five years after implantation.

For more information:

Dec. 18, 2009 Ear, Nose and Throat Devices Panel Meeting:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/EarNoseandThroatDevicesPanel/ucm146740.htm

FDA's Center for Devices and Radiological Health—Hearing Aids

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/HearingAids/default.htm

Media Inquiries:  Peper Long, 301-796-4671; mary.long@fda.hhs.gov

Consumer Inquiries:  888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Back to top

RELATED LINKS
http://www.fda.gov/

'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/9/2017)... AirXpanders, Inc. (ASX: AXP) (AirXpanders or Company), ... sale and distribution of the AeroForm® Tissue Expander System, ... commercial roll-out in the United States ... hundred (100) medical institutions and health systems, located throughout ... alternative for women who choose reconstructive surgery following a ...
(Date:6/8/2017)... 8, 2017  StatLab Medical Products ("StatLab" ... manufacturer of diagnostic supplies for the anatomic ... & Company LP ("Cressey & Company"), a ... growth-focused investment in the Company. Cressey & ... from selling shareholder, Prairie Capital, L.P., with ...
(Date:6/5/2017)... , June 5, 2017 The Cincinnati ... of Diplomat Pharmacy, Inc. (NYSE: DPLO), has been awarded a ... Enquirer . Results are based on an employee ... organizational health and workplace improvement. The survey measures several aspects ... ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... , ... Ross Insurance Agency ( http://www.rossinsuranceagency.com ) saves clients ... (FEMA) recent update of flood zones, more people than ever are in flood ... to reflect the actual risk in flood zone areas during a time when ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... ... management, financial planning, and related services to families and business owners in and ... charity drive to benefit senior citizens in the area. , Meals on Wheels ...
(Date:6/23/2017)... ... June 23, 2017 , ... Radabaugh & Associates, a ... and business owners in North Central West Virginia, is embarking on a cooperative ... abled residents in the region. , The Stepping Stones organization offers a series ...
(Date:6/22/2017)... ... June 22, 2017 , ... Plastic Surgery Associates is proud to ... for 2017. Each year, research and information firm, Castle Connolly, releases their list of ... 2015, this marks the 3rd time that Dr. Canales has been recognized ...
(Date:6/22/2017)... ... June 22, 2017 , ... Children’s National Health ... Association (AHA) to launch a Rheumatic Heart Disease Center, with the goal of ... rheumatic heart disease (RHD) in high-risk, financially disadvantaged countries and low-income communities across ...
Breaking Medicine News(10 mins):