JOHN LI, M.D.
OTOLOGY NEUROTOLOGY RESOURCES
210 Jupiter Lakes Blvd #5105
Jupiter, FL 33458
Fact Sheet: The Esteem® Hearing Implant
The Esteem® Hearing Implant is a truly innovative hearing solution.
|The Esteem® Hearing Implant is the only FDA-approved, fully implanted, active middle ear hearing device.|
|Unlike conventional hearing solutions, with the Esteem, there are no external components and nothing is placed in the recipient’s ear canal.|
|The Esteem® is specifically engineered to help improve the hearing of adults diagnosed with moderate to severe sensorineural hearing loss.|
The Esteem® is designed for adults with sensorineural hearing loss.
|Sensorineural hearing loss is the most common type of hearing loss, particularly as we age.|
|The Esteem® is significantly different than a “cochlear implant.”|
|The Esteem® is a middle ear implant, while a cochlear implant is an inner ear implant. Each addresses different degrees of hearing loss.|
|The Esteem® is indicated for those with a moderate to severe hearing loss, 40dB to 90dB. A cochlear implant is for the profoundly deaf, those individuals with greater than 90 dB of hearing loss.|
Multiple advantages set the Esteem® apart from other hearing solutions.
|Because the Esteem® is fully implanted, it’s invisible. There are no external components and nothing is placed in the recipient’s ear canal. The net result is that Esteem® recipients don’t just hear and look better, they typically feel better about themselves as well.|
|Instead of utilizing an artificial microphone or speaker like conventional hearing solutions, the Esteem® actually uses the body’s natural anatomy to improve a recipient’s hearing.|
|Because the Esteem® is fully implanted, recipients enjoy remarkable convenience. There’s nothing to put in or take out. Which also means there’s nothing to clean, misplace, or forget. And no daily maintenance.|
|The Esteem® is 100% waterproof. An Esteem® recipient can exercise, shower, and even swim underwater—without any problem. There is a restriction for scuba divers—scuba diving is permitted down to 30 feet. Snorkeling and all other water activities are encouraged. All of which promotes newfound freedom and a go-anywhere lifestyle.|
|The Esteem® is uniquely designed to be a long-term hearing solution. This distinction enables it to be a full-time performer that’s up to the task—24/7/365. Even its battery is engineered to last from 4.5 to 9 years, depending upon its hours of use and volume settings.*|
*Please note, if an Esteem® recipient is continuously exposed to excessively loud sounds and is using the highest gain settings, battery life can be reduced. Bench testing under these conditions demonstrated that battery life could be as short as 2.8 years.
Four key components comprise the Esteem® Hearing Implant.
Four advanced, precision-crafted components make up the Esteem® Hearing Implant’s innovative design:
|The Esteem® Sensor picks up vibrations from the eardrum, malleus, and incus bones, converts them into electrical signals, and sends them to the Sound Processor.|
|The Esteem® Sound Processor, which is implanted behind a recipient’s ear, receives, filters, and increases the Sensor’s signals before sending them to the Driver.|
|The Esteem® Driver receives the processor’s signals and converts them into mechanical vibrations that drive the stapes and stimulate the cochlea.|
|The Esteem® Personal Programmer allows recipients to conveniently turn their implant on and off, adjust the volume, and select one of three unique program settings to fit a specific need.|
|All of the Esteem’s implanted components are made of the same highly reliable, bio-safe materials found in millions of other implanted medical devices such as pacemakers.|
The Esteem® Hearing Implant requires surgery and a recovery period.
|The Esteem® Hearing Implant can only be implanted by an Esteem-trained surgeon. Most recipients go home from the surgery center the same day as their surgery.|
|While individual recipients heal at different rates, the Esteem® is typically turned on, at the surgeon’s discretion, approximately 8 weeks after surgery.|
If necessary, the Esteem® can be implanted in both ears.
|The best possible hearing situation for many recipients is to have bilateral hearing. Currently, bilateral implants can be done in separate Esteem® procedures conducted several months apart.|
The Esteem® is a product of American ingenuity.
|The Esteem® Hearing Implant is designed, manufactured, and marketed by Envoy Medical Corporation of St. Paul, Minnesota.|
|The company was originally established as St. Croix Medical in 1994 and changed its name to Envoy Medical in 2006.|
|Envoy Medical Corporation’s mission is to be the leading implantable hearing therapy company leveraging the ear’s natural microphone to provide optimal hearing improvement.|
|On August 27, 2009, the FDA notified Envoy Medical that it had received the Esteem® PMA (Pre-Market Approval) application and decided to grant the application expedited processing for the following reason: “We believe that the Esteem® Totally Implantable Hearing System represents a breakthrough technology, which provides an alternative to non-implantable and partially implantable hearing aid technology.”|
|On March 17, 2010, Envoy Medical received a formal PMA approval letter from the FDA granting approval for commercial distribution of The Esteem® Hearing Implant.|
Copyright © 2013 John Li M.D. All Rights Reserved