Ear Center: About the ESTEEM Device
The Envoy ESTEEM - A Totally Implantable Active Middle Ear Device for Treatment of Moderate-to-Severe Hearing Loss
Navigate this page:
Hearing Loss & The ESTEEM
About Ears and Hearing
How We Hear
Types of Hearing Loss
How ESTEEM Improves Hearing
What Makes ESTEEM Absolutely Unique?
ESTEEM Battery Life
Having an ESTEEM Implant Operation
What to Expect
Indications and Contraindications
Graphic of the ESTEEM Device
Hearing is an essential part of human life. It is estimated that ten percent of the world population has hearing problems. Without treatment, people with hearing loss experience social isolation, and are more prone to psychological illness, depression, anxiety and paranoia. Loss of hearing means loss of information, networking and economic power for an individual and the economy. The ESTEEM is the only fully implantable hearing device for sensorineural hearing loss that uses the natural ear as a microphone. It is a surgically implanted device to help improve hearing and enhance the quality of your life.
First, we consider ears and how they work naturally when we hear. Then, we review different types of hearing loss. Finally, we learn about ESTEEM Hearing Implant, which can improve hearing for many people with hearing loss.
Three main parts of the ear help with hearing:
- the outer ear
- the middle ear and
- the inner ear
The outer ear consists of the pinna, which is the visible portion of the ear, and the ear canal that leads to the eardrum. The pinna is responsible for collecting sound waves and funneling them into the ear canal, which amplifies certain frequencies (particularly the high frequencies necessary to understand human speech) and filters out others as it directs sound waves to the eardrum. The eardrum separates the outer ear from the middle ear.
The middle ear is a small cavity between the eardrum and the inner ear. The middle ear contains three bones; they are the malleus (hammer), the incus (anvil) and the stapes (stirrup). These three bones are connected together to form the ossicular chain which carries sound vibrations from the eardrum to the inner ear.
The inner ear contains the cochlea, which resembles a snail shell. The cochlea turns the mechanical sound vibrations into electrical signals that are transmitted to the brain via the auditory nerve. The electrical signals are interpreted by the brain and recognized as sound.
Sound waves travel in all directions from their source through the air. Each part of the ear plays a role in hearing sound waves.
- The pinna captures sound waves from the air, focuses them, and directs them into the ear canal.
- The ear canal acts as a resonating tube, emphasizing certain frequencies that are important in speech, particularly the high frequencies between 3000 to 6000 Hz.
- The sound waves strike the eardrum and cause the eardrum to vibrate.
- The small bones in the middle ear- the malleus, incus and stapes - amplify and transmit the vibrations from the eardrum to the oval window of the inner ear.
- When the oval window of the inner ear vibrates, it causes the fluid inside the cochlea to move. This movement causes the hearing hair cells to move. The hair cells are connected to nerve endings which convert this movement into electrical signals.
- The auditory nerve sends the electrical signals to the brain, where they are interpreted as meaningful sound.
Hearing loss may occur:
- as a result of aging
- genetic predisposition
- an illness or injury
- or as a result of years of exposure to loud sounds (which cause intense vibrations that damage the hair cells inside the cochlea).
When hearing loss is caused by damage to the inner and outer hair cells or other parts of the cochlea, it is called sensorineural hearing loss. The damage makes it more difficult for the cochlea to convert these sound waves into electrical signals.
Conductive hearing loss is a reduction in hearing sensitivity that is caused by interference with the passage of sound through the outer or middle ear. As a result of this interference, the sound is blocked or disrupted. The interference may be caused by several different factors including excessive fluid build-up in the middle ear, perforation of the ear drum, or ossicular chain malfunction.
When hearing loss is caused by a combination of sensorineural and conductive problems, it is called mixed hearing loss.
The ESTEEM is designed to help improve the hearing of adults with moderate to severe sensorineural hearing loss. ESTEEM is implanted in the mastoid (bone behind the external ear) and in the middle ear. The technology consists of a Sound Processor that is implanted behind the outer ear, and two piezoelectric transducers (called the Sensor and Driver) that are implanted in the middle ear. Because all the parts of ESTEEM are implanted, ESTEEM is invisible to you and to others. The materials used to make ESTEEM have been proven safe and reliable in millions of pacemakers and other implanted medical devices. ESTEEM uses your own eardrum along with the malleus and incus as a natural microphone, picking up sounds through the ear canal, thereby using the body's natural anatomy to reduce the background noise, distortion, and acoustic feedback that people experience with conventional hearing aids.
The Sensor is coupled to the ossicular chain. It picks up vibrations from the eardrum, malleus, and incus bones and converts the vibrations into electrical signals. These signals are sent to the Sound Processor.
The Sound Processor, which is implanted behind the ear, filters and increases the electrical signals and sends them to the Driver. The Sound Processor is computer programmed by your Audiologist to customize ESTEEM settings for your particular hearing needs. The Sound Processor case also contains the battery.
The Driver is coupled to the stapes in the middle ear. The Driver converts the electrical signals that it has received from the Sound Processor back into mechanical vibrations and transmits these signals to the stapes and to the cochlea.
The Personal Programmer is your personal "remote control" that may be used:
- to turn your ESTEEM "On" or "Off"(standby)
- select the volume and
- select one of three unique program settings (A, B, and C programs)
You will be able to adjust your ESTEEM to your own comfort level no matter where you are - at home, using the telephone, in a crowded restaurant, or on a noisy street.
Completely implanted - Completely invisible
Nobody notices when you have the Esteem implanted. When you look in the mirror in the morning, you're not reminded of your hearing aid. You can still switch the Esteem "On" and "Off" and regulate the volume with a convenient Personal Programmer.
No microphone - No noise interference
ESTEEM uses the ear canal, the eardrum and two of the hearing bones as a natural microphone in the form of a "smart bridge". In this way, the ear filters out background noise naturally. There is no acoustic feedback. Many surgeons have termed the ESTEEM Hearing Implant, an "electronic prosthetic hearing device".
No charging - No maintenance
ESTEEM's maintenance-free battery lasts 4.5 - 9 years, depending on use. Once it is depleted, the battery is replaced in a minor outpatient operation performed under local anesthesia with sedation. Changing batteries every two weeks and laborious batter recharging are things of the past.
The battery life of the Esteem will vary depending on the number of hours the device is left on and the average sound level the ESTEEM is exposed to during the day. The ESTEEM will remain on as long as the patient does not turn the implant off by using the Personal Programmer to switch to the "Standby Mode". Unlike hearing aids and partially implantable hearing devices, the patient has the realistic option of leaving the device on 24 hours each and every day. The fully implantable ESTEEM does not have to be turned off during showering, during water sports and swimming, or while sleeping.
The following battery life estimates assume that the patient is exposed to a typical amount of sound while his or her ESTEEM is on and active. The estimates were determined by laboratory testing and mathematical extrapolation. Results, which may not be typical, from some clinical trial patients indicate that these estimates may be conservative and that battery life may be longer under "real life" conditions*.
- 4.5 years - 24 hours per day/7 days per week
- 6.5 years - 16 hours per day/7 days per week
- 9 years - 8 hours per day/7 days per week
* Please note, if an ESTEEM patient is continuously exposed to excessively loud sound levels (90 dB SPL, 24 hours per day) and is using the highest gain settings, battery life can be reduced. Testing under these worst case scenario conditions demonstrated that battery life could be as short as 2.8 years.
ESTEEM Battery Replacement Indicator (ERI)
The ESTEEM triggers a battery "elective replacement indicator" (ERI) when the battery begins to deplete.
The ERI is indicated by the Personal Programmer confirmation tone changing from a single tone to a dual tone. Also, the "ESTEEM Low Battery LED" will illuminate on your Personal Programmer.
ESTEEM Battery End of Life (EOL)
EOL occurs approximately 2 weeks after the ERI is first indicated. This assumes that you use the Personal Programmer during this time frame and can, therefore, notice the first time that ERI is indicated. Contact your Audiologist immediately when a two-tone Personal Programmer confirmation tone is heard or when the Personal Programmer shows an illuminated "ESTEEM Low Battery LED". This will enable sufficient time to schedule replacement of the ESTEEM battery.
ESTEEM Battery (Sound Processor) Replacement
The Sound Processor Battery is changed in an outpatient surgical procedure. The Sound Processor/Battery change is performed by your surgeon using local anesthesia and takes approximately one hour. The same incision is used that was used for the initial implant procedure, however, the incision is more limited. After this outpatient surgery, your ESTEEM is turned on and programmed the same day.
The operation to surgically implant the ESTEEM involves standard techniques for mastoid surgery in addition to an extended facial recess surgical approach to access the ossicular chain. An incision is made behind the ear to allow access to the mastoid and middle ear spaces. During the implant procedure, the ossicular chain is disarticulated (surgically separated). The tip of the Sensor is positioned in the attic, and the Driver extends into the middle ear. The surgeon couples the Sensor and Driver to your incus and stapes, respectively. The Sound Processor is implanted behind the ear, under the scalp. Insulated wires connect the Sound Processor to the Sensor and Driver.
For approximately eight weeks after the operation, you will not be able to hear through the ear in which ESTEEM is implanted. This is due to the fact that your ESTEEM will not yet be activated. Your physician will determine when the ESTEEM can be "turned-on" or activated.
After it is implanted, the ESTEEM is completely invisible to others. It does not interfere with bathing, showering, swimming, or other normal physical activities.
Although all operations are potentially serious, the type of ear surgery used to implant the ESTEEM is rarely dangerous. The hospital stay is generally brief. Middle ear surgery is done for many reasons. Patients must carefully read and understand the risks associated with implantation of the ESTEEM. However, the surgical risks should be considered.
Risks may include, but not be limited to, the following:
- mild postoperative pain along the behind-the-ear incision
- need for eventual battery replacement when the battery naturally depletes
- inability to have an MRI scan after the ESTEEM implant
- mild to moderate taste disturbance
- fluid behind the eardrum for up to 6 weeks after the operation
- mild numbness along the incision for up to 6 weeks after the operation
- prolonged taste disturbance
- facial weakness or paralysis on the side of the implant, either immediate or delayed
- transient or prolonged vertigo, unsteadiness, or dizziness
- postoperative infection, either early or delayed
- partial or total loss of hearing in the implanted ear
- failure to be able to implant the ESTEEM in the mastoid or middle ear
- reaction to anesthesia
- need for revision, explantation, and/or reconstruction
- soft or hard device failure
- other risks and complications that can not be predicted
ESTEEM is intended to treat hearing loss in patients by simulating the actions of the ossicular chain and by providing additional gain with low distortion.
The ESTEEM is indicated for patients with sensorineural hearing loss who meet the following criteria:
- 18 years of age or older
- Stable bilateral sensorineural hearing loss
- Moderate to severe sensorineural hearing loss defined by Pure Tone Average (Range = 40 dB - 70 dB, as determined by averaging pure tone air thresholds at 500, 1000, and 2000 Hz)
- Unaided Speech Discrimination test score greater than or equal to 40%
- Normally functioning Eustachian tube
- Normal middle ear anatomy
- Normal tympanic membrane
- Adequate space for ESTEEM implant determined via high resolution CT scanning of the temporal bones
- Minimum 30 days of experience with appropriately fit hearing aids
ESTEEM is contraindicated under the following conditions:
- History of post-adolescent chronic middle ear infections, inner ear disorders or recurring vertigo requiring treatment, disorders such as mastoiditis, Endolymphatic Hydrops or Meniere's syndrome or disease
- Candidate has a known history of fluctuating air conduction and/or bone conduction hearing loss over the past one year period of 15 dB in either direction at 2 or more frequencies (from 500 to 4000 Hz)
- History of otitis externa or eczema of the outer ear canal
- Cholesteatoma or destructive middle ear disease
- Retrocochlear or central auditory disorders
- Disabling tinnitus, defined as tinnitus which requires treatment
- History of keloid formation
- Hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
- A pre-existing medical condition or undergoing a treatment that may affect the healing process
- The ESTEEM Hearing Implant should not be implanted during pregnancy
- Implanting surgeons should consider psychological, developmental, physical, or emotional disorders before implanting this device
Avoiding Head Injury
After the ESTEEM is implanted, the recipient should avoid contact sports or other activities that could result in a head injury. Participation in contact sports may result in damage to the patient's hearing or the ESTEEM implanted components.
Electroconvulsive Therapy (ECT) must never be used on a patient who has an implanted ESTEEM because it may damage the patient's hearing or the ESTEEM.
If electrocautery is used, ensure that the ESTEEM is turned off.
Never allow current from an electrosurgical (electrocautery) instrument to be applied directly to an ESTEEM® component, to avoid the risk of damage to the implanted component or to the patient's hearing. Use only a bipolar electrocautery system and never use over or near the ESTEEM implant.
Magnetic Resonance Imaging
You cannot undergo Magnetic Resonance Imaging (MRI) examination or be in close proximity to MRI devices after you have had ESTEEM implanted. Fields produced by the MRI may damage your ESTEEM or cause it to operate improperly.
Avoiding High Pressure
After the ESTEEM is implanted, the patient should avoid diving to depths of more than 10 meters (30 feet) of water as this may result in damage to the ESTEEM.
Cell Phone Use/Cell Phone Compatibility
Because there are a wide range of cellular telephones and other wireless devices on the market, it is not possible to ensure ESTEEM compatibility with all products. In a clinical study that included 70 subjects, seven subjects (10%) reported experiencing noise or feedback when using a cellular or wireless device. In all cases, the noise or feedback only occurred during cellular or wireless device usage and had no long term effects on ESTEEM or the subject. If unpleasant noise or feedback occurs when using your ESTEEM with a cellular or wireless device, you should discontinue use of the cellular or wireless device with the ear that has the ESTEEM.
Physical Activities and Sports
When your surgeon says that it is okay, you may return to most of the activities you enjoyed before receiving your ESTEEM. Avoid contact sports and physical activities that could result in a hard blow to your head. Avoid diving deeper than 10 m (30 ft) of water, as this may result in damage to your ESTEEM. If you have any questions concerning your activities, check with your surgeon.
Pushing or Twisting the Implanted Parts of Your ESTEEM
Avoid pushing or twisting the implanted parts of your ESTEEM, such as the Sensor and Driver leads. Either action can cause skin erosion or damage to various parts of the ESTEEM. Skin erosion or ESTEEM damage may require surgery to correct.
ESTEEM may set off security devices in airports. If it does, show your identification card (provided by Envoy Medical after implantation) to the security guard and ask to be hand wanded over the area of the ESTEEM. The identification card is described in detail in later pages of this brochure. Security systems and metal detectors could temporarily interrupt your hearing. To restore normal hearing, simply move away from the source of interference. All people while traveling experience pressure changes of the middle ear during flight. ESTEEM recipients should expect to experience the same subtle changes in hearing and periods of temporary plugged sensations during air travel.
Your ESTEEM is designed to be resistant to interference produced by other electrical equipment such as household appliances. You may safely operate all common household appliances and office equipment. It is possible that while operating these appliances or equipment, you may hear noise/interference. However, ESTEEM programming will be unaffected. Moving away from the source will, in most cases, mitigate any potential interference.
Clothing and Protective Equipment
Helmets and hats do not present a problem as long as they do not put a significant amount of pressure on the side of the head behind the ear where the Sound Processor is implanted. As customary in loud environments, the use of an earplug is recommended.
Diagnostic Medical Tests
If you are going to undergo a medical treatment or diagnostic procedure, you must notify your physician that you have an ESTEEM implant(s).
The effects on the ESTEEM of:
- positron emission tomography (PET) scans
- radio frequency (RF) ablation
- transcutaneous electrical nerve stimulation (TENS)
- and other electronic therapies have not been tested
If you require such treatment, you should let your physician know to consult with the Envoy Medical Corporation for current safety information regarding these therapies.
During all these types of therapies, the ESTEEM device should always be turned off to avoid interference noises.
X-Ray image quality directly around the implant could be compromised. Please avoid electroconvulsive therapy on or near the Sound Processor implant.
During emergency use of a defibrillator, the ESTEEM should be switched off to avoid interference noises. If emergency defibrillation is necessary or elective cardioversion is desired, the ESTEEM performance and integrity should not change. If ESTEEM is left on (active) during these procedures, you may hear interference and performance could change temporarily. However the long-term performance and integrity should not change whether left on (active) or turned off (standby mode). If you believe you have experienced any changes after this procedure, please contact your implanting surgeon or Envoy Medical Corporation.
If your profession requires you to be in the vicinity of a high electrical current, consult your physician before engaging in such activities.
- People who smoke need to be aware that smoking can affect healing after any surgical procedure, including implantation of ESTEEM.
- People with diabetes mellitus that is not well controlled with either medication or diet need to take extra precautions with their surgeon to discuss post-operative healing issues.
- Air-bone gap indicating a conductive or mixed hearing loss should be reviewed by a surgeon.
- The ESTEEM Implant has an approximate revision/enhancement rate of 5%, requiring patients to have an additional surgical procedure to increase benefit. During the most recent clinical trial, a 2% explant rate was reported.
CAUTION: Federal Law restricts this device to sale by or on the order of a physician.
© 2011 Envoy Medical Corporation or its affiliates. All rights reserved.
Esteem® and Envoy Medical® are registered trademarks of Envoy Medical Corporation.
Published on this web site with the permission of Envoy Medical Corporation.
After you have contacted Envoy Medical and have been through screening, you may contact our office at (336) 273-9932 and ask for our Audiology Department.
1. Tysome JR, Moorthy R, etal. Systematic review of middle ear implants: do they improve hearing as much as conventional hearing aids? Otol Neurotol 2010:31(December):1369-1375.
To learn more about our implant team and our office, please visit the our ESTEEM web pages.
Last revised May 9, 2011