written by guest writer Dr. Terry D. Portis
Crossposted from New Hearing
Part 1, Dec. 18, 2009
The hearing health field is being rapidly transformed by advancing medical technologies.
Earlier this year I was appointed by the FDA as the consumer representative to the ENT Medical Devices Panel. They wanted someone who could read and interpret scientific data, while also maintaining a consumer perspective. Given my personal background as a family member of a person with a cochlear implant, and my professional background with the Hearing Loss Association, they thought I would be a good fit. The FDA lists my speciality as “educational psychology.”
Today the ENT Panel reviewed the Envoy Esteem device. The Esteem is a breakthrough device and gives us a glimpse into the future of hearing technology. It is a totally implanted middle ear device. There are no external parts. I will talk a little more about the technology aspects in the second post.
I had the privilege of spending a few minutes at breakfast this morning with Dr. Leopold, an ENT from Omaha. Dr. Leopold is also chairman of this panel. He worked at Johns Hopkins, and was familiar with the excellent reputation of Anne Arundel Community College. He was surprised that the college has grown to have more than 55,000 students.
The 16 experts on the panel represented various fields, and they either had an M.D. Or Ph.D. Panel members were surgeons, physicians, audiologists, professors and researchers from all over the country. I quickly came to the conclusion that this group represented some of the best minds in the hearing health field. The FDA certainly outdid themselves in coming up with a high level group of conscientious and caring professionals.
At the end of the day, the ENT Panel voted to recommend approval for the device. The recommendation was unanimous. Here is the link to a breaking press announcement.http://www.medcitynews.com/index.php/2009/12/fda-panel-approves-envoy-impantable-ear-device/
Part 2, Dec. 19, 2009
This post represents my own understanding of the Envoy Esteem device.
The Envoy Esteem is the first totally implantable hearing device, geared towards people with moderate to severe hearing loss. Researchers first began working on the concept 23 years ago. There is no microphone, the device uses the eardrum and the sensor for a more natural hearing experience.
Here is a website with more information: http://www.envoy.us.com/Envoy_device.htm
The surgery is similar to cochlear implant surgery. The device is completely invisible, and recipients can swim, shower, hike, etc. Some of the components, such as the battery, use pacemaker technology.
If you use the device 24/7, your battery will last about 4.5 years. If you limit use to 8 hours per day, you could see 9 years of battery life. My guess is that most people will keep it running. You also have a wireless remote, to adjust the settings if you like.
Positives: It is invisible, there is no maintenance or cleaning, long battery life.
Negatives: A delicate procedure with similar risks to other middle ear procedures. Specially trained and skilled surgeons are required.
Part 3, Dec. 21, 2009
Part III: Why I think this is important:
Two generations ago, Self Help for Hard of Hearing founder Rocky Stone called hearing loss “an invisible disability.” We are fast approaching the day when it is just “invisible.”
Part 4, Dec. 21, 2009
Part IV: Personal testimonies
In the afternoon of the FDA panel deliberations, several recipients of the Envoy Esteem device gave personal accounts. This was a personal highlight for me. All of them led very active lifestyles, and had not been too fond of their hearing aids.
There were three mothers of small children (in their 20’s and 30’s), a dentist in her 40’s, two gentlemen in their 60’s, and a woman in her 50’s. Nothing about them would have clued you in to their hearing loss. If you were to try to pick them out of the crowded gallery you would have been unable to do so.
The dentist described her frustration of trying to hear over a drill. One young mom talked about now being able to hear her child who frequently gets sick in the middle of the night. One woman talked about being able to use the telephone at work by just picking it up and answering it like everyone else. One mom talked about realizing her toddler always sings to herself in the backseat.
One of the older gentlemen talked about how he still says “what” after everything his wife says to him. He has developed a habit of doing it for years, but doesn’t need to because he can hear her. This gentleman took early retirement as a corporate CEO because of his hearing issues.
One gentleman, an otologist, talked about how he can go canoeing again and hear what he going on. He said, he wasn’t that great at canoeing, and ended up in the water frequently. This is no longer a problem.
The word that stuck me about each person coming to the microphone was “self-confidence.” There were lots of people in the gallery, and the people were speaking to a panel full of M.D. and Ph.D. types. Not a problem.