The FDA regulates manufacturers of cochlear implants. For manufacturers to sell cochlear implants in the United States, they must first show the FDA that their implants are safe and effective. As a matter of policy, FDA does not rate or recommend brands of cochlear implants or medical facilities that implant them.
What Is a Cochlear Implant?
A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.
These implants usually consist of 2 main components:
- The externally worn microphone, sound processor and transmitter system.
- The implanted receiver and electrode system, which contains the electronic circuits that receive signals from the external system and send electrical currents to the inner ear.
Currently made devices have a magnet that holds the external system in place next to the implanted internal system. The external system may be worn entirely behind the ear or its parts may be worn in a pocket, belt pouch, or harness.
Who Uses Cochlear Implants
Cochlear implants are designed to help severely to profoundly deaf adults and children who get little or no benefit from hearing aids. Even individuals with severe or profound "nerve deafness" may be able to benefit from cochlear implants.
What Determines the Success of Cochlear Implants?
Many things determine the success of implantation. Some of them are:
- How long the patient has been deaf--as a group, patients who have been deaf for a short time do better than those who have been deaf a long time
- How old they were when they became deaf--whether they were deaf before they could speak
- How old they were when they got the cochlear implant--younger patients, as a group, do better than older patients who have been deaf for a long time
- How long they have used the implant
- How quickly they learn
- How good and dedicated their learning support structure is
- The health and structure of their cochlea--number of nerve (spiral ganglion) cells that they have
- Implanting variables, such as the depth and type of implanted electrode and signal processing technique
- Intelligence and communicativeness of patient
How Does a Cochlear Implant Work?
A cochlear implant receives sound from the outside environment, processes it, and sends small electric currents near the auditory nerve. These electric currents activate the nerve, which then sends a signal to the brain. The brain learns to recognize this signal and the person experiences this as "hearing".
The cochlear implant somewhat simulates natural hearing, where sound creates an electric current that stimulates the auditory nerve. However, the result is not the same as normal hearing.
Current thinking is that the inner ear responds to sound by at least two separate ways.
One theory, the place theory, says the cochlea responds greater to a simple tone at one place along its length. Another theory is that the ear responds to the timing of the sound.
Researchers, following the place theory, devised implants that separated the sound into groups. For example, they sent the lower pitches to the area of the cochlea where it seemed more responsive to lower pitches. And they sent higher pitches to the area more responsive to high pitches. Thus, they used several channels and electrodes spaced out inside the cochlea. Since there were also timing theories, researchers devised implants that made the sound signals into pulses to see if the cochlea would respond better to various kinds of pulses.
Most modern cochlear implants are versatile, in that they are somewhat capable of being adjusted to respond to sound in various ways. Audiologists try a variety of adjustments to see what works best with a particular patient.
The first commercial devices were approved by the FDA in the mid-1980's. However, research with this device began in the 1950's.