Cochlear Implants

Center for Devices and Radiological Health

PDF Print

Deli.cio.us    Digg    reddit    Facebook    StumbleUpon    Newsvine

Risks from the Surgical Implant Procedure

  • Injury to the facial nerve --this nerve goes through the middle ear to give movement to the muscles of the face. It lies close to where the surgeon needs to place the implant, and thus it can be injured during the surgery. An injury can cause a temporary or permanent weakening or full paralysis on the same side of the face as the implant.
  • Meningitis --this is an infection of the lining of the surface of the brain. People who have abnormally formed inner ear structures appear to be at greater risk of this rare, but serious complication. For more information on the risk of meningitis in cochlear recipients, please refer to FDA's Public Health Notification: http://www.fda.gov/cdrh/safety/101007-cochlear.html and its Advice to Patients: http://www.fda.gov/cdrh/medicaldevicesafety/atp/101007-cochlear.html
Read more... [Center for Devices and Radiological Health]
 

Cochlear Implant FAQ

PDF Print

Deli.cio.us    Digg    reddit    Facebook    StumbleUpon    Newsvine

What is a Cochlear Implant?

A cochlear implant is a small, complex electronic device that can help to provide a sense of sound to a person who is profoundly deaf or severely hard-of-hearing. The implant consists of an external portion that sits behind the ear and a second portion that is surgically placed under the skin (see figure). An implant has the following parts:

  • A microphone, which picks up sound from the environment.
  • A speech processor, which selects and arranges sounds picked up by the microphone.
  • A transmitter and receiver/stimulator, which receive signals from the speech processor and convert them into electric impulses.
  • An electrode array, which is a group of electrodes that collects the impulses from the stimulator and sends them to different regions of the auditory nerve.

An implant does not restore normal hearing. Instead, it can give a deaf person a useful representation of sounds in the environment and help him or her to understand speech.

Who Gets a Cochlear Implant?

Children and adults who are deaf or severely hard-of-hearing can be fitted for cochlear implants. According to the Food and Drug Administration (FDA), at the end of 2006, more than 112,000 people worldwide had received implants. In the United States, roughly 23,000 adults and 15,500 children have received them.

Adults who have lost all or most of their hearing later in life often can benefit from cochlear implants. They learn to associate the signal provided by an implant with sounds they remember. This often provides recipients with the ability to understand speech solely by listening through the implant, without requiring any visual cues such as those provided by lipreading or sign language.

Cochlear implants, coupled with intensive postimplantation therapy, can help young children to acquire speech, language, and social skills. Most children who receive implants are between two and six years old. Early implantation provides exposure to sounds that can be helpful during the critical period when children learn speech and language skills. In 2000, the FDA lowered the age of eligibility to 12 months for one type of cochlear implant.

 

How Does a Cochlear Implant Work?

A cochlear implant is very different from a hearing aid. Hearing aids amplify sounds so they may be detected by damaged ears. Cochlear implants bypass damaged portions of the ear and directly stimulate the auditory nerve. Signals generated by the implant are sent by way of the auditory nerve to the brain, which recognizes the signals as sound. Hearing through a cochlear implant is different from normal hearing and takes time to learn or relearn. However, it allows many people to recognize warning signals, understand other sounds in the environment, and enjoy a conversation in person or by telephone.

 

How Does Someone Receive a Transplant?

Use of a cochlear implant requires both a surgical procedure and significant therapy to learn or relearn the sense of hearing. Not everyone performs at the same level with this device. The decision to receive an implant should involve discussions with medical specialists, including an experienced cochlear-implant surgeon. The process can be expensive. For example, a person’s health insurance may cover the expense, but not always. Some individuals may choose not to have a cochlear implant for a variety of personal reasons. Surgical implantations are almost always safe, although complications are a risk factor, just as with any kind of surgery. An additional consideration is learning to interpret the sounds created by an implant. This process takes time and practice. Speech-language pathologists and audiologists are frequently involved in this learning process. Prior to implantation, all of these factors need to be considered.

What are Symptoms of a Bad Transplant?

Injuries from cochlear implant devices may differ in intensity, but some common symptoms include:

  • Pain in ear
  • Discomfort
  • Loss of sound
  • Cracking, hissing and popping noises
  • Sudden loud noises

 

 

Preti Flaherty Amends Lawsuit Against Advanced Bionics for Selling Faulty Cochlear

PDF Print

Deli.cio.us    Digg    reddit    Facebook    StumbleUpon    Newsvine
April 11, 2008 (Boston, MA) – Preti Flaherty amended the complaint filed against Advanced Bionics Corporation in United States District Court for the District of Massachusetts for providing Marilyn Rappaport of Randolph, Massachusetts with a faulty cochlear implant.  The amended complaint refers to the U.S. Food and Drug Administration’s March 28, 2008 press release announcing that it is seeking a $2.2 million penalty against Advanced Bionics and its CEO Jeffrey Greiner for violating federal law applicable to the manufacture of medical devices.  This is the maximum fine available under federal law for violations adjudicated in a single proceeding.
Read more... [Preti Flaherty Amends Lawsuit Against Advanced Bionics for Selling Faulty Cochlear]
 


© 2008 leflaw.com design by tracy feldman