Envoy Medical Corporation recently unveiled the newest surgical option for hearing impaired individuals after obtaining approval for commercial distribution from the FDA in March 2010. The Esteem, a fully implantable hearing device, is the first and only hearing device that does not use a microphone or a speaker. It can be worn at all times and, unlike a traditional hearing aid, does not have to be taken off during showering or swimming.
The Esteem is comprised of a sensor, sound processor and a driver, all of which are surgically implanted into the middle ear. The sensor attaches to one of the tiny bones, called the incus, in the middle ear. These bones pick up sound vibrations from the eardrum and convert them from mechanical energy to electronic signals. The sound processor, implanted outside of the middle ear, receives the electronic signals from the sensor and sends the information to the driver. The sound processor is the component of the device that can be programmed by your hearing healthcare provider. The driver is cemented to another of the middle ear bones, the stapes, and converts the electrical stimulus back to mechanical stimulation, which is then sent to the inner ear.
Users of the Esteem receive a personal programmer, which acts as a remote control so that the user can turn the Esteem on and off, change programs and control the volume of the device. The battery for the device is an estimated 6 to 9 years, at which time the battery is replaced via a surgical procedure.
Currently, candidacy for the Esteem is as follows:
- 18 years of age or older
- Stable moderate to severe sensorineural hearing loss (hearing loss caused by a deterioration or abnormality in the inner ear or hearing nerve) The *Esteem is different than a cochlear implant as a cochlear implant is a device implanted into the inner ear and is appropriate for those with hearing losses that are profound in nature.
- Minimum of 90 days of experience with a traditional hearing aid
- Normal middle ear, eardrum and Eustachian tube function
The most common side effects experienced by users of the Esteem implant are:
- Taste disturbance (metallic taste caused by severing of Chorda Tympani nerve. Occurred in 60% of trial cases)
- Pain
- Dizziness
- Nausea
- Device Failure
Esteem is still in the early stages of implementation, thus there are only a handful of surgeons that are licensed to perform the surgery. Surgeons must complete a three part training and only about 30% of surgeons pass the training. Currently, there have been 500 Esteem surgeries completed.
The cost of the Esteem is $30,000 per ear. The downside is that the surgery and device are not covered by insurance, thus the price is out of pocket. The battery replacement runs around $4,500 to $5,000 for each device. Envoy does provide financing options for the Esteem.
The Esteem device is not without controversy. The company states that if the device fails or if the benefit is unsatisfactory, another surgery is required. During the process of implantation, one of the bones of the middle ear is cut, therefore requiring a prosthesis if the device is removed. There is a significant drop in hearing when the device is turned off, even more significant than what the wearer’s hearing loss was prior to surgery due to the disarticulation of the middle ear bones. In addition, individuals with the Esteem implant cannot undergo MRIs due to the metal components of the device.
For more information on the Esteem middle ear implant, visit http://www.envoymedical.com/
