The health and safety information contained herein is provided for informational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider while considering the unique characteristics of the patient. Federal Law restricts this device to sale by or on the order of a physician.
INDICATIONS FOR ESTEEM
The Esteem is intended to alleviate hearing loss in patients by replicating the ossicular chain and providing additional gain. The Esteem is indicated for patients with hearing loss that 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 (PTA)
Unaided speech discrimination tests score greater than or equal to 40%
Normally functioning Eustachian tube
Normal middle ear anatomy
Normal tympanic membrane
Adequate space for the Esteem implant determined via a high-resolution CT scan
Minimum 30 days of experience with appropriately fit hearing aids
CONTRAINDICATIONS FOR ESTEEM
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, Hydrops or Meniere’s syndrome or disease
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 for the outer ear canal
Cholesteatoma or destructive middle ear disease
Retro cochlear 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 healing process
RISKS AND POTENTIAL ADVERSE EVENTS
The following information describes potential adverse events that may be possible with the Esteem:
Erosion of the Sound Processor through the skin or infection to the Sound Processor pocket
During the surgical implant procedure, your surgeon may determine that your anatomy does not allow enough space for the proper implant of the Esteem. These instances do arise in approximately 3% of the implant procedures. In this case, the Esteem will not be implanted and the surgical procedure will be terminated.
Intraoperative injury to the malleus, incus, stapes or cochlea because of physical contact and placement of the Sensor/Driver portion of the device.
Cold, sinus or upper respiratory congestion may result in temporary reduced benefit of Esteem
Esteem may offer limited or no benefit, requiring an additional surgery to revise, enhance, replace or remove any or all of the components. During the most recent clinical trial, a 5% revision replacement surgery and a 2% explant rate were reported.
Esteem may produce mechanical feedback, requiring an additional surgery to revise, enhance, replace or remove any or all of the components
Loss of attachment of leads from Sound Processor, and/or transducers from mastoid, and/or ossicular chain bones, requiring surgery to revise, replace or remove any or all of the components
Loss or worsening of hearing after reconstruction of the ossicular chain in the event of device explant. The amount or degree of loss is dependent upon the method of reconstruction (PORP, TORP or ossicular reconstruction). Please consult your physician regarding the options. A PORP or TORP is an ossicular replacement prosthesis.
Damage to the stapes or cochlea as a result of removal of the Sensor or Driver connection during surgery, revision or removal of the Esteem
Dislocation of any of the middle ear bones
Bleeding and postoperative infection
As with any surgical procedure, risks and complications can occur. Below is a list of potential adverse events that may occur from the surgical procedure used to implant the Esteem. Subsequent surgeries to change the Sound Processor/Battery have some of the same potential risks, as many of these complications are associated with any operative intervention. Please consult your surgeon before electing this procedure to appreciate the risks associated with the Esteem implant procedure.
Bodily soreness that is associated with intraoperative positioning of the body and a prolonged implant procedure
Temporary loss of skin sensation in and about the ear may occur following surgery. This numbness may involve the entire outer ear and usually resolves in the months following the procedure.
Temporary dizziness, light-headedness or vertigo
During the Esteem implant procedure one of the three nerves involved in taste (the chorda tympani) may be severed, as done in other middle ear surgeries. Taste disturbance can be a side effect of severing this nerve. Patients reported taste disturbance as mild in intensity and typically temporary in nature.
Formation of fibrous tissue in the middle ear subsequent to surgical intervention may occur. The likelihood and amount is determined by many surgical and patient variables and can vary greatly amongst patients.
Infection and/or wound infection may occur following surgery
Intraoral discomfort, jaw soreness or stiffness
Temporary facial paresis/paralysis or numbness was reported by up to 7% of the subjects in the clinical trial
Eardrum perforation (temporary rupturing) and/or drainage from ear canal
Neurological complications associated with being under general anesthesia for an extended period of time
Physical dislocation or fracturing of the malleus, incus, and/or stapes bones
Partial or total loss of remaining hearing in the implanted ear
Widening or thickening of the scar behind the ear
Complications related to anesthesia may occur
Cerebral spinal fluid leak and meningitis
The occurrence or changes in existing tinnitus (perception of ringing of sound) may occur
Please consult your physician before engaging in this procedure to assess the potential occurrence of any of these complications.
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 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 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 Health Care Professional says it is okay, you can 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 Health Care Professional.
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. 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, the programming is 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.
If you are going to undergo a medical treatment or diagnostic procedure, you must notify your physician that you have the Esteem.
The effects on the Esteem of positron emission tomography (PET) scans, ultrasound, diathermy, radiation, lithotripsy, 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 Envoy Medical 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 that is not well controlled with medication or diet need to take extra precaution with their surgeon to discuss post-operative healing issues.
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 trial a 2% explant rate was reported.
Air-bone gap indicating a conductive or mixed hearing loss has not been studied with Esteem.
Implanting surgeons should consider psychological, developmental, physical, or emotional disorders before implanting this device.