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.
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:
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.
MRI CONDITIONAL SAFETY INFORMATION
The implanted components of the Esteem System, which includes a Model 2001 Sound Processor with the 7002/7004/7010 sensors and 7502/7504/7510 drivers, are MR Conditional and are safe for MRI scans under certain conditions. Please refer to the document entitled “MRI Conditional Safety Information” for more information.
Esteem MRI Conditional Safety Information
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.