What is an implantable hearing aid or device?
An implantable hearing aid or device is an alternative available to patients who cannot or will not wear traditional hearing aids. All implantable hearing aids or devices transmit and amplify sound in order that the patient may hear. A number of implantable hearing aids involve placing a magnet in the middle ear, on one of the bones in the middle ear or on the cochlea, the organ of hearing. The internal or external microphone picks up the sound, sends it to the magnet, which then vibrates the middle or inner ear, allowing the person to hear. Others involve placing an abutment or magnet on the skull and once healing has occurred, a processor is attached to the abutment or magnet which sends the sound to the better hearing nerve through vibrations across the skull.
There are two types of implantable hearing aids or devices: fully implantable hearing aids and partially implantable hearing aids or devices.
Fully implantable hearing aids or devices are devices that have an internal device that is implanted by the surgeon with nothing visible on the outside of the head. The device may have a remote control to adjust the volume or program on the hearing aid or device. They also may have an internal battery which is also implanted and may require additional surgery once the battery is no longer functioning. One example of a fully implantable hearing device is the Esteem by Envoy Medical. Further information is available at their website: www.envoymedical.com.
Partially implanted hearing aids or devices are hearing devices that have an internal device that is implanted by the surgeon along with an external device that is worn on the head, behind the ear or in the ear. One benefit of a partially implantable hearing aid or device is having the battery in the external device, which eliminates the need for additional surgery for replacement of the battery. This also allows for updates to the processor through programming software that would not require additional surgery.
There are several options available for a partially implanted device for persons who have a sensorineural hearing loss: the Vibrant SoundBridge by MedEl Corporation (www.medel.com) and the Maxum by Ototronix (www.MyMaxum.com). Both devices utilize an implanted magnet in the middle ear space with an external microphone worn either on the side of the head or in the ear canal. B oth are classified by the FDA as a Class III implantable device .
If you have a conductive or mixed hearing loss or a profound sensorineural hearing loss in one ear and normal hearing on the opposite side (also known as single sided deafness), you have options known as bone anchored hearing technology: the Baha System by Cochlear Americas (www.cochlearamericas.com), the Ponto and Ponto Pro by Oticon Medical (www.oticonmedical.com) and the Alpha 1 Hearing System by Sophono (www.sophono.com). The Baha System, Ponto and Ponto Pro are all categorized by the FDA as osseointegrated cochlear stimulators which consist of an abutment (a cone shaped screw that is implanted in the skull by the surgeon and a processor which picks up the sound and sends it to the better hearing nerve. The Baha System and the Ponto line both use a titanium abutment which is visible when the processor is not in use. The Alpha 1 Hearing System utilizes a surgically implanted magnet, which is not visible when the processor is not in use. Please see their websites for additional information.
Who is a candidate?
Each device has received FDA (the U.S. Food and Drug Administration) approval for a range of hearing loss as well as word recognition ability, how well a person can understand words once they are presented at a loud enough level based on the hearing loss. Typically, the guidelines are for a mild to severe sensorineural hearing loss with word recognition ability of 60% or better. Many of the devices, but not all, are FDA approved for sensorineural, conductive or mixed hearing losses. The FDA as well as the device manufacturers strongly recommends the patient has undergone a trial of at least 30 days with an appropriately fit traditional hearing aid prior to getting an implantable device.
Does insurance cover the cost of the surgery and the device?
That seems like such an easy question, but it can be confusing. Many of the devices are covered by health insurance, dependent on your specific policy as well as what FDA category the device is in. Very few health insurance companies offer coverage for a hearing aid, traditional or implantable. It is very important to refer to the device you are interested in by the FDA approved name. Many devices were initially approved by the FDA as a hearing aid, and then were re-categorized as an implantable device, such as an osseointegrated cochlear stimulator. An osseointegrated cochlear stimulator is covered by many insurance policies, but hearing aids are not. It is recommended that you contact your insurance carrier to determine if the device and surgery are covered by your policy. Please ask your audiologist or the surgery coordinator for the appropriate billing codes prior to contacting your insurance carrier. Pittsburgh Ear Associates will also obtain any pre-certification or pre-authorization necessary prior to your surgery.
Other alternatives to traditional hearing aids and implantable hearing aids or devices
There are other options available to traditional hearing aids or implantable hearing aids or devices that do not require surgery. For single-sided deafness or conductive hearing loss, one such device is the SoundBite by Sonitus Medical (www.sonitusmedical.com). The SoundBite is comprised of 2 parts: an In-the-Mouth (ITM) device that attaches to your back molars and a behind-the-ear microphone that picks up the sound and sends the signal to the ITM which then sends the sound through vibration to your better hearing ear or hearing nerve. There are dental as well as hearing requirements that will need to be met in order to be a candidate for the SoundBite. Both components can be removed when you are not using the device or for example, when you are eating.
Other precautions with implantable hearing aids or devices
Once you receive an implantable device, there are precautions you must take to avoid damage to the device or yourself. A person with any implantable device that has a magnet as one of its components CANNOT have an MRI, monopolar cautery or electro-shock therapy. A person with an abutment must remove the processor prior to having an MRI, however, an MRI near the abutment area requires the removal of the abutment prior to the MRI. The abutment can be replaced once the MRI has been completed. The use of a MedicAlert (www.medicAlert.com) bracelet (or similar identifying item) is highly recommended in case of an emergency. It is also encouraged that you have on your person at all times the patient identification card for your device as this may be needed during security screening procedures, ie., at the airport or courthouses for example.