JOHN LI, M.D.
OTOLOGY NEUROTOLOGY RESOURCES
210 Jupiter Lakes Blvd #5105
Jupiter, FL 33458
Envoy Esteem® - FAQ's
What is the Esteem®?
The Esteem® is the only FDA approved, fully implanted hearing device. The Esteem® does not use an artificial microphone or speaker, but rather, your natural ear canal. It has no external components in the ear canal or around the ear. This means that with the Esteem, you can hear 24/7 without compromising your lifestyle. With no daily maintenance and the ability to be fully submerged underwater, the Esteem® is a true game changer.
Will this work for me? Where can I go to get evaluated?
The Esteem® is used to treat moderate to severe sensorineural hearing loss. Sensorineural hearing loss is the most common type of hearing loss, occurring when cochlear hair cells are damaged. For this device to work as designed, there cannot be anything wrong with the ear except for damaged hair cells in the cochlea. Also, it is not possible to have the Esteem® in an ear in which you have had any major previous surgery. Our Esteem® Certified Audiologist can evaluate your hearing and let you know if Esteem® is an option for your hearing loss. If the Esteem® is right for you, schedule an appointment with Dr. Li to discuss surgery.
What is involved in the implant?
The first step is the hearing evaluation performed by our audiologists. They will determine if the Esteem® may be an appropriate option for your specific hearing loss. Dr. Li will then perform your medical evaluation, including a CT scan to determine if you have enough space in the mastoid cavity for the implant (it is uncommon not to have enough space, but this is something that needs to be known before surgery). Once you are ready and approved for surgery, the Esteem® is fully implanted with surgery under general anesthesia (you are asleep) that takes approximately 4 hours. It is routinely done as an outpatient procedure and doesn't typically require an overnight stay. You will be taken care of by both your Esteem® Certified Audiologist and Dr. Li. 8 weeks after surgery, the device needs to be turned on. This time allows the middle ear to heal before the implant becomes active. Then, 2 to 3 months later the Esteem® can be fine-tuned for your specific hearing loss. Consult your audiologist or Dr. Li for more specific details.
What is the success rate for the Esteem® after surgery?
The success rate is incredibly high. 97% of patients implanted after the FDA approval show a demonstrable improvement in their audiometric evaluations. The 3% that didn't have successful results were caused by infections and poor audiological performance. The technology is very reliable with a failure rate of less than 1%. Satisfaction rates are more subjective, and dependant on preoperative expectations.
If it is totally implanted, how does the patient adjust the volume?
The Esteem® comes with a Personal Programmer, which is essentially the patient's own "remote control". It can turn the Esteem® on or off and adjust the volume or switch between the three unique programs set by the Audiologist.
How much does the Esteem® cost?
The cost of the Esteem® includes the surgical costs to implant it. It is not a hearing aid, it's a surgically implanted device that essentially helps your natural ear perform better. The procedure is performed by a highly skilled and trained surgeon and takes about four hours under general anesthesia. Exact costs are specific to the surgical site. The ballpark cost is typically around $40,000 to have an ear implanted. The Esteem® Certified Audiologist in your area can discuss the specific costs with you if you would like to make an appointment to be evaluated for this procedure.
Does the Esteem® have a battery? How often do I have to change it?
The Esteem® has a battery that lasts approximately 4.5 to 9 years. (Based on laboratory testing, battery life may be reduced to 2.8 years if continually exposed to very loud sound levels using the highest gain settings.) Once the battery is depleted it is replaced in a 45 minute to an hour outpatient procedure, generally done under local anesthesia (you are not asleep). When you get a new battery, you are also getting a new Sound Processor with all of the advances to date. Exact costs are specific to the surgical site. The ballpark cost is typically around $7,000 - $10,000.
Is the Esteem® covered by insurance?
The Esteem® is not currently covered by most insurance and is a cash pay procedure.
How does it work?
The Esteem® is designed for hearing loss caused by damaged hair cells in the cochlea. It senses the natural vibration of the eardrum and use this signal to drive the stapes bone a little harder than the natural ear can, magnifying the sound waves. This leverages the natural design of hearing anatomy. Check out Envoy's animation showing how the Esteem® works in greater detail.
How long has the Esteem® been around? How many implants have been performed?
The Esteem® received CE certification in 2006, which allowed Envoy Medical to market and sell the Esteem® in various European countries. In 2010, Envoy Medical was given FDA approval after a unanimous panel vote. The first clinical trial patients were implanted in 2004. There have been over 650 implants in the U.S. and approximately 800 worldwide.
Can I have the device implanted in both ears?
Yes, an Esteem® can be implanted in each ear, however, the surgeries cannot be done at the same time. Typically there is a six month wait before the second implant can be done, but this needs to be verified with your surgeon.
What if the patient's hearing loss changes over time?
Sensorineural hearing loss can be progressive and worsen over time. The Esteem® cannot prevent additional hearing loss (which is why hearing protection remains important) but it can be programmed to adjust with the patient's hearing loss needs over time. If the patient's hearing loss progresses beyond where the Esteem® can be effective, other options can be considered at that time. The Esteem® procedure generally does not preclude a patient from having a cochlear implant in the future.
What if the patient wants to have the device removed at a later date?
With a 97% success rate, it is rare for patients to be unsatisfied with the Esteem® implant. However, it is still possible to remove an Esteem® implant if necessary. During the implant of the Esteem®, a portion of the long process of the incus bone is removed. If a patient chooses to have an explant, the ossicular chain generally may be rebuilt using a prosthetic. The level of hearing loss after the reconstruction will vary depending on the circumstances.
What caused the explants?
The most common causes for explants are infection and the growth of fibrotic tissue. Some people will grow fibrotic tissue after surgery which can interfere with the function of the implant. This tissue can generally be removed; however,there are some people that will continue to re-grow this fibrotic tissue making it impractical to keep the device.
What potential complications and/or side-effects are there from the implant procedure?
The Esteem® is implanted in a surgical procedure performed under general anesthesia. As with any surgery, especially those done under general anesthesia, there are risks and potential complications that will be discussed in the surgeon's office. Specific to the Esteem® surgery, taste disturbance and facial paresis are tracked. In the surgical procedure, the surgeon must sometimes cut the chorda tympani, which is the nerve associated with taste. This can result in a taste disturbance that most patients describe as a metallic taste in their mouth. For most patients this goes away over time, but can linger or be permanent. The surgeon will be working in the area of the facial nerve and therefore facial nerve monitors are used during surgery to prevent injury. If a person tends to swell a lot, this can put pressure on the facial nerve causing a numb or tingly sensation on that side of the face. Your surgeon will be able to give more details on the surgical procedure. During the clinical trial for the Esteem®, 57 individuals were implanted at three investigational centers. The side-effects observed in the clinical study included:
|Taste disturbance: 42% of subjects (14% ongoing after 1 year)|
|Facial paresis 7% of subjects (1% ongoing after 1 year)|
Will I like this device?
It is important to remember that hearing is both a subjective and a quality of life issue that affects every aspect of an individual's life. The patient is in the best position to decide how important addressing their hearing loss is to them and what risks the patient is willing to assume in the process. However, the vast majority of Dr. Li's patients have had successful implants and are enjoying life to the fullest!
These questions and answers are designed to inform you as much as possible about the details of the Envoy Esteem implant. Consult your Esteem® Certified Audiologist for more information, or visit the Envoy Esteem website at Envoymedical.com
Copyright © 2013 John Li M.D. All Rights Reserved