3.18.10 | Thomas Lee

FDA approves Esteem hearing device

The Food and Drug Administration has approved Envoy Medical Corp.’s Esteem technology, the first fully implantable device to treat hearing loss in the United States.

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

Envoy plans to start implanting 100 patients a month beginning in October at a new surgical center the company is building in Houston, which it will open in three months. The company is recruiting surgeons to train at its headquarters in White Bear Township and a facility in Greensboro, N. C.

For Envoy, convincing physicians to embrace the new technology will be a top challenge, which is why the FDA approval is so important, CEO Patrick Spearman said in an interview.

“Once you get FDA approval, it’s just fun to talk to doctors,” he said.

Esteem also comes with a hefty price tag: $30,000 out of pocket. But Spearman says the ultimate benefit–restoration of hearing loss–makes Esteem “a good value.”

In normal hearing, sound causes the ear drum to vibrate, moving fluid inside the cochlea, an oval-shaped area in the inner ear. The motion prompts tiny hairs to touch nerve endings, which converts the movement into electric signals sent to the brain.

In conductive hearing loss, sound moving through outer and middle ear is blocked. Sensorineural hearing loss is more severe–the hairs don’t vibrate properly, disrupting the electric signals to the brain.

Hearing aids, which rely on microphones to amplify sound, are flawed devices because they don’t effectively filter out unwanted noise. Patients are also self-conscious of wearing the devices.

The Esteem is located entirely in the ear. The system consists of a sensor, sound processor and driver. The sensor picks up vibrations from the ear drum and converts them into electric signals. The sound processor, a specially designed computer chip, cleans up the signals and boosts its power. Finally, the driver converts the signals back into mechanical vibrations and transmits them into the cochlea.

Spearman noted Envoy raised more than $100 million entirely from prominent angel investors, which gave the company time (15 years) to develop and perfect the technology; venture capitalist firms, by contrast, would have demanded a much earlier return.

Envoy’s investors include Minnesota Timberwolves owner/billionaire Glen Taylor, Roger Lucas of biotech firm Techne Corp., and former Medtronic Inc. vice chairman Glen Nelson. Former Boston Celtic great Kevin McHale, Spearman’s brother-in-law, also chipped in $400,000.

Given the regulatory and financial pressures confronting the industry today, Spearman says it “will cost more money and take more time” to commercialize technology than start-ups think.

Aside from a roster of high profile angels, Envoy benefitted from an enormous market of people willing to pay big bucks to recover their hearing, he said.

“There’s just not a lot of [blockbuster] implantable devices out there anymore,” Spearman said.

Thomas Lee

Thomas Lee was the Minnesota Bureau Chief for MedCityNews.

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Tags: Envoy Medical, medical devices, Minnesota, U.S. Food and Drug Administration

Comments Post a comment

This is wonderful news. Is it benifical to deaf people. When do you project it will be available
to the masses of people who don’t have big bucks to spend? I have a relative who will be 89 this year and I know she can’t afford the $30,000. price. For years, after spendinf big bucks on hearing aids she describes the problem as a lady on the TV segment describes it-unable to hear normal conversation due to its picking up all background noises. Again, this is Great!

Dorcas Bennett

Comment by Dorcas bennett — May 29, 2010 @ 6:49 pm

My mother is 81. We consider the cost would be like buying a nice car. If it provides a person to hear clearly what is being said and not just background noises, well awesome. We have probably spent close to $30,000 in the past 10 years buying aids, batteries, gas and our time that we have devoted to trying to get some clear ears. Hope to see you soon.
HS

Comment by Holly Strother — May 31, 2010 @ 4:51 pm

this would be wonderful for my 15 yr old grandson who has been hearing impaired since birth-we are constantly researching and trying to find anything to improve his quality of hearing and life-please forward any contacts or information you have so that we can start the process for our grandson-thank you-this would be a true miracle in his life

Comment by terry tierney — June 1, 2010 @ 1:51 pm

great yes, but how many people can afford $30,000.00….I have BCBS, yet they will pay nothing
on my husband hearing issues…He has no eardrum in his left and only partial hearing in his right ear….i don’t get the insurance companies…Its not like he’s faking hearing loss….

Comment by marilyn futrell — August 17, 2010 @ 1:19 pm

third time typing request to take part in clinical trials in texas and n.c. please excuse trping handicapped hunt and peck,one hand.. maybe rhird time will be charm

Comment by MAX SMITH — September 7, 2010 @ 8:12 pm

is there any way to find out about clinical trials in Texas or Greensboro N C I would be so greatful
Many Thanks Joyce Llorens

Comment by Joyce llorens — September 9, 2010 @ 11:15 am

this sounds great! I would also like to know about the clinical trials in Texas or Greensboro N.C. Thank you. Donna Evans

Comment by Donna Evans — September 9, 2010 @ 2:08 pm

I am ready…. the sooner the better!

Comment by peggy prosser — September 9, 2010 @ 2:43 pm

I would like to know about the clinical trials. I’m 64 yrs old and have been losing my hearing since I was in my late 20′s early 30′s. Don’t think I have the money but would like more information.

Thank-you. Vikki Heimsoth

Comment by Vikki Heimsoth — September 10, 2010 @ 6:15 pm

Will this help hearing impairment due to nerve damage

Comment by jackie blanchard — September 11, 2010 @ 4:33 pm

I would like to have additional information. For example, how long does the surgery take? How long is the recuperation period? Is financing available, and if so, how does it work? Are there any new developments pending that would make waiting a few months worthwhile?

Comment by john summers — September 20, 2010 @ 9:48 am

It sounds too good to be true lets wait for the first few patiens to have it done and then find out
if will it work the way they say it will. If will restore the hearing that is good news but only the
rich could effort thirty grant patiens should wait till price come down and be effortable.

Comment by Arthur Reppas — October 7, 2010 @ 9:14 pm

Age 71, having hearing difficulties. I have tried hearing aids but they do not seem to provide the help move that I need. Rush Limbaugh was talking about Esteem and felt that it might help my hearing difficulty. However being poor does present some stumbling blocks. $30,000 plus is definitely out of the question for me. Having just retired from a janitorial position, but still driving a school bus, limits the amount of money that I have available. If there should be some help out there would be interested in knowing about it.
William Fisher

Comment by William A Fisher — October 10, 2010 @ 2:11 pm

I wonder if this would help those who suffer from tinnitus? Is there a remote control device involved?

Comment by Vernon Osborne — October 17, 2010 @ 4:52 am

Is there any type insurance or discounts that will help pay for this miracle discovery? Do you need any guina pigs for further study? Retired, living on SS income and raising two grandchildren so money is tight. Does anyone offer grants?

C. Lee West

Comment by Calvin Lee West — October 24, 2010 @ 1:50 pm

Hi, sounds great, I heard about on the Rush Limbaugh show. During the inplant will there be any removal of natrual inner bone or inner ear parts, in case we need to go back to a hearing aid?
Thanks

Comment by Doug Fick — November 2, 2010 @ 11:49 pm

I Live in Massachusetts, We have some of the best hospitals in the country. I would definitely be interested in clinical trials in the Boston area asap. I had the mumps as a child and have worn hearing aids for nearly 40 years. Insurance companies won’t pay for such a procedure apparently don’t consider people with hearing deficits important.

Comment by CHERYLCRAFFEY — November 22, 2010 @ 6:13 pm

Great i have been suffering from SN hearing loss from my 3rd age…now 35 yrs. but the cost
hope it will be affordable to all in coming years..Anyway Waiting for Clinical result..of this new
invention..Regards

Comment by Navaz C P — December 18, 2010 @ 11:53 am

HOW LONG BEFORE DR’S ARE TRAINED AND THE PROCEDURE CAN BE DONE LOCALLY. DOES THE INSURANCE CO. PAY FOR ANYTHING?

Comment by S. M. ALBRECHT — January 22, 2011 @ 4:38 pm

I have Advanced Bionics in my left ear. Would they be able to still do the procedure on that ear? ….Is the 30,000.00 for both ears or just one? …..Is recovery time same as with choclear implant?……….Thank you

Comment by Ann Moore — February 3, 2011 @ 6:34 pm

My parents were hard of hearing. TV was always blaring.
Began losing hearing in the my 40′s. Both brothers are hard of hearing but only one wears an aid. I’m 70 and have grown with hearing aid improved technology. I would Iike helping in further medical studies….Thank you.

Comment by Patricia Hamilton — March 22, 2011 @ 8:58 am

Will this device give hearing to people who have loss from childhood Menigitis nerve damage

Comment by Carroll Piper Sr. — June 5, 2011 @ 11:37 am

Are they implanting children? My son has a sensorineural hearing loss, moderate-to-severe loss, and is 14. I would love to see him free of hearing aides.

Comment by Arlene Hardman — October 19, 2011 @ 10:05 pm