Medication errors by Jaikumar pareta

Medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm. These errors can occur while the medication is in the control of the health care professional, patient, or consumer.

Medication errors can occur at any time in the medication use process, including during prescribing, dispensing, administering, and monitoring. A medication error can result in patients getting the wrong formulation, strength, dose, frequency, or even the wrong drug. Approximately 54,000 suspected U.S. medication error cases were submitted to FDA in 2014.

Drug name confusion can cause medication errors

There are many ways in which drug name confusion can cause medication errors, such as similarity in spelling and pronunciation that result in prescribing or dispensing of the wrong medication. In addition, analysis of name confusion errors has shown that other factors, such as shared strength or dose between products, may also contribute to name confusion and has led to errors involving drugs with similar names. However, this is not always the case as errors have also been reported despite differences in product strength.

Another contributing factor that can lead to drug name confusion is confirmation bias, the tendency to search for, interpret, or recall information in a way that confirms one’s beliefs or hypotheses. When a product has been on the market for some time and has name recognition, familiarity with the drug name has been known to cause confirmation bias.

Efforts to avoid drug name confusion before approval

FDA’s safety review of a proposed proprietary name focuses on the prevention of medication errors.  We recommend that sponsors submit their requests for FDA’s review of their proposed proprietary name as soon as they have the recommended supporting information described in the “Contents of a Complete Submission for the Evaluation of Proprietary Names” guidance.

When FDA reviews a proposed proprietary name for either a new brand name drug or new generic drug application, we look for error-prone naming attributes and potential sources for error, including the spelling and pronunciation of the name as well as its appearance when scripted.  We also perform prescription simulation studies with FDA health care professionals by asking them to interpret a proposed proprietary name in simulated real-world use conditions.  The results of these studies are analyzed carefully to identify the vulnerability of the proposed name to be misinterpreted by health care professionals.

Further, we evaluate the similarity of names by using FDA’s Phonetic and Orthographic Computer Analysis (POCA) program to identify names that look or sound like the proposed proprietary name.  After identifying potential look-alike/sound-alike names, proposed proprietary names are analyzed further using the principles of failure modes and effects analysis (FMEA), a systematic tool that helps us to determine where failures might occur in the medication-use system with the proposed product.

We also evaluate the proposed proprietary name to make sure it is not misleading by misrepresenting the product’s safety or efficacy.

Reporting medication errors to FDA

Even with our thorough pre-marketing drug name review process, the potential for unexpected confusion still exists.  We strongly encourage all reports of medication errors in the United States to be reported to FDA through MedWatch, the agency’s adverse event reporting system. We evaluate reports from pharmaceutical companies, health care professionals, and patients that we receive through this system.  We also review reports from other sources including the Institute for Safe Medication Practices.  With this information, we are able to apply the “lessons learned” to improve our drug name review process.

Addressing name confusion errors and informing the public

When we receive a medication error report, we evaluate it to understand the root cause of the error and review pertinent information, such as labeling and packaging.  Once an error is identified, FDA may recommend that the sponsor make changes to the labeling and packaging of the product.  Changes have been made to the presentation of the drug name on the container label and/or carton labeling by incorporation of mixed case letters, different font size, layout, and color.

In rare cases, we’ve worked with sponsors to change a proprietary name to resolve medication errors resulting from name confusion.  FDA may also employ drug safety communications, consumer updates, or scientific publications to inform the public about medication errors.  In addition, the sponsor may conduct outreach to the public about medication errors through mass mailings of letters, emails, educating drug representatives, and reaching out directly to pharmacies and wholesalers.

Help combat drug name confusion errors

In order to help reduce drug name confusion errors, we encourage health care professionals to be aware of drug names that look and sound alike, and identify drug names that may be problematic. Pharmacists and nurses should match the drug’s indication to the patient’s condition before dispensing or administering the product.  It is also important for patients to always double-check their medications and ask their health care provider or pharmacist about medications that look or sound different than expected.

The future of reducing the risk of drug name confusion errors

Last year, FDA published the draft guidance for industry – “Best Practices in Developing Proprietary Names for Drugs.”  This guidance is intended to help sponsors of drugs and biologic products develop proprietary names that do not cause or contribute to medication errors or misbrand a drug. As we go forward, we continue to diligently evaluate proposed proprietary names and post-marketing error reports to minimize the potential for drug name confusion and prevent medication errors. 

Stress & relaxation techniques By Jaikumar pareta

Stress — just the word may be enough to set your nerves on edge. Everyone feels stressed from time to time. Some people may cope with stress more effectively or recover from stressful events quicker than others. It's important to know your limits when it comes to stress to avoid more serious health effects.

What is stress?

Stress can be defined as the brain's response to any demand. Many things can trigger this response, including change. Changes can be positive or negative, as well as real or perceived. They may be recurring, short-term, or long-term and may include things like commuting to and from school or work every day, traveling for a yearly vacation, or moving to another home. Changes can be mild and relatively harmless, such as winning a race, watching a scary movie, or riding a rollercoaster. Some changes are major, such as marriage or divorce, serious illness, or a car accident. Other changes are extreme, such as exposure to violence, and can lead to traumatic stress reactions.

How does stress affect the body?

Not all stress is bad. All animals have a stress response, which can be life-saving in some situations. The nerve chemicals and hormones released during such stressful times, prepares the animal to face a threat or flee to safety. When you face a dangerous situation, your pulse quickens, you breathe faster, your muscles tense, your brain uses more oxygen and increases activity—all functions aimed at survival. In the short term, it can even boost the immune system.

However, with chronic stress, those same nerve chemicals that are life-saving in short bursts can suppress functions that aren't needed for immediate survival. Your immunity is lowered and your digestive, excretory, and reproductive systems stop working normally. Once the threat has passed, other body systems act to restore normal functioning. Problems occur if the stress response goes on too long, such as when the source of stress is constant, or if the response continues after the danger has subsided.

How does stress affect your overall health?

There are at least three different types of stress, all of which carry physical and mental health risks:

• Routine stress related to the pressures of work, family and other daily responsibilities.
• Stress brought about by a sudden negative change, such as losing a job, divorce, or illness.
• Traumatic stress, experienced in an event like a major accident, war, assault, or a natural disaster where one may be seriously hurt or in danger of being killed.

The body responds to each type of stress in similar ways. Different people may feel it in different ways. For example, some people experience mainly digestive symptoms, while others may have headaches, sleeplessness, depressed mood, anger and irritability. People under chronic stress are prone to more frequent and severe viral infections, such as the flu or common cold, and vaccines, such as the flu shot, are less effective for them.

Of all the types of stress, changes in health from routine stress may be hardest to notice at first. Because the source of stress tends to be more constant than in cases of acute or traumatic stress, the body gets no clear signal to return to normal functioning. Over time, continued strain on your body from routine stress may lead to serious health problems, such as heart disease, high blood pressure, diabetes, depression, anxiety disorder, and other illnesses.

How can I cope with stress?

The effects of stress tend to build up over time. Taking practical steps to maintain your health and outlook can reduce or prevent these effects. The following are some tips that may help you to cope with stress:

• Seek help from a qualified mental health care provider if you are overwhelmed, feel you cannot cope, have suicidal thoughts, or are using drugs or alcohol to cope.
• Get proper health care for existing or new health problems.
• Stay in touch with people who can provide emotional and other support. Ask for help from friends, family, and community or religious organizations to reduce stress due to work burdens or family issues, such as caring for a loved one.
• Recognize signs of your body's response to stress, such as difficulty sleeping, increased alcohol and other substance use, being easily angered, feeling depressed, and having low energy.
• Set priorities-decide what must get done and what can wait, and learn to say no to new tasks if they are putting you into overload.
• Note what you have accomplished at the end of the day, not what you have been unable to do.
• Avoid dwelling on problems. If you can't do this on your own, seek help from a qualified mental health professional who can guide you.
• Exercise regularly-just 30 minutes per day of gentle walking can help boost mood and reduce stress.
• Schedule regular times for healthy and relaxing activities.
• Explore stress coping programs, which may incorporate meditation, yoga, tai chi, or other gentle exercises.

• How much do we know about relaxation techniques?

  A substantial amount of research has been done on relaxation techniques. However, for many health conditions, the number or size of the studies has been small, and some studies have been of poor quality.

  What do we know about the effectiveness of relaxation techniques?

  Relaxation techniques may be helpful in managing a variety of health conditions, including anxiety associated with illnesses or medical procedures, insomnia, labor pain, chemotherapy-induced nausea, andtemporomandibular joint dysfunction. Psychological therapies, which may include relaxation techniques, can help manage chronic headaches and other types of chronic pain in children and adolescents. Relaxation techniques have also been studied for other conditions, but either they haven't been shown to be useful, research results have been inconsistent, or the evidence is limited.

  What do we know about the safety of relaxation techniques?

  Relaxation techniques are generally considered safe for healthy people, although there have been a few reports of negative experiences such as increased anxiety. People with serious physical or mental health problems should discuss relaxation techniques with their health care providers.

  What Are Relaxation Techniques?

  Relaxation techniques include a number of practices such as progressive relaxation, guided imagery, biofeedback, self-hypnosis, and deep breathing exercises. The goal is similar in all: to produce the body's natural relaxation response, characterized by slower breathing, lower blood pressure, and a feeling of increased well-being.
  Meditation and practices that include meditation with movement, such as yogaand tai chi, can also promote relaxation. 
  Stress management programs commonly include relaxation techniques. Relaxation techniques have also been studied to see whether they might be of value in managing various health problems.

  The Importance of Practice

  Relaxation techniques include the following:

  Autogenic Training

  In autogenic training, you learn to concentrate on the physical sensations of warmth, heaviness, and relaxation in different parts of your body.

  Biofeedback-Assisted Relaxation

  Biofeedback techniques measure body functions and give you information about them so that you can learn to control them. Biofeedback-assisted relaxation uses electronic devices to teach you to produce changes in your body that are associated with relaxation, such as reduced muscle tension.

  Deep Breathing or Breathing Exercises

  This technique involves focusing on taking slow, deep, even breaths.

  Guided Imagery

  For this technique, people are taught to focus on pleasant images to replace negative or stressful feelings. Guided imagery may be self-directed or led by a practitioner or a recording.

  Progressive Relaxation

  This technique, also called Jacobson relaxation or progressive muscle relaxation, involves tightening and relaxing various muscle groups. Progressive relaxation is often combined with guided imagery and breathing exercises.

  Self-Hypnosis

  In self-hypnosis programs, people are taught to produce the relaxation response when prompted by a phrase or nonverbal cue (called a “suggestion”).

  What the Science Says About the Effectiveness of Relaxation Techniques

  Researchers have evaluated relaxation techniques to see whether they could play a role in managing a variety of health conditions, including the following:

  Anxiety

  Studies have shown relaxation techniques may reduce anxiety in people with ongoing health problems such as heart disease or inflammatory bowel disease, and in those who are having medical procedures such as breast biopsies or dental treatment. Relaxation techniques have also been shown to be useful for older adults with anxiety.

  On the other hand, relaxation techniques may not be the best way to help people with generalized anxiety disorder. Generalized anxiety disorder is a mental health condition, lasting for months or longer, in which a person is often worried or anxious about many things and finds it hard to control the anxiety. Studies indicate that long-term results are better in people with generalized anxiety disorder who receive a type of psychotherapy called cognitive-behavioral therapy than in those who are taught relaxation techniques.

  Asthma

  There hasn't been enough research to show whether relaxation techniques can relieve asthma symptoms in either adults or children.

  Childbirth

  Relaxation techniques such as guided imagery, progressive muscle relaxation, and breathing techniques may be useful in managing labor pain. Studies have shown that women who were taught self-hypnosis have a decreased need for pain medicine during labor. Biofeedback hasn't been shown to relieve labor pain.

  Depression

  An evaluation of 15 studies concluded that relaxation techniques are better than no treatment in reducing symptoms of depression but are not as beneficial as psychological therapies such as cognitive-behavioral therapy.

  Epilepsy

  There's no reliable evidence that relaxation techniques are useful in managing epilepsy.

  Fibromyalgia

  • Studies of guided imagery for fibromyalgia have had inconsistent results.
  • A 2013 evaluation of the research concluded that electromyographic (EMG) biofeedback, in which people are taught to control and reduce muscle tension, helped to reduce fibromyalgia pain, at least for short periods of time. However, EMG biofeedback didn't affect sleep problems, depression, fatigue, or health-related quality of life in people with fibromyalgia, and its long-term effects haven't been established.

  Headache

  • Biofeedback. Biofeedback has been studied for both tension headaches and migraines.
    • An evaluation of high-quality studies concluded that there's conflicting evidence about whether biofeedback can relieve tension headaches.
    • Studies have shown decreases in the frequency of migraines in people who were using biofeedback. However, it's unclear whether biofeedback is better than a placebo.
  • Other Relaxation Techniques. Relaxation techniques other than biofeedback have been studied for tension headaches. An evaluation of high-quality studies found conflicting evidence on whether relaxation techniques are better than no treatment or a placebo. Some studies suggest that other relaxation techniques are less effective than biofeedback.

  Heart Disease

  In people with heart disease, studies have shown relaxation techniques can reduce stress and anxiety and may also have beneficial effects on physical measures such as heart rate.

  High Blood Pressure

  Stress can lead to a short-term increase in blood pressure, and the relaxation response has been shown to reduce blood pressure on a short-term basis, allowing people to reduce their need for blood pressure medication. However, it's uncertain whether relaxation techniques can have long-term effects on high blood pressure.

  Insomnia

  There's evidence that relaxation techniques can be helpful in managing chronic insomnia. Relaxation techniques can be combined with other strategies for getting a good night's sleep, such as maintaining a consistent sleep schedule; avoiding caffeine, alcohol, heavy meals, and strenuous exercise too close to bedtime; and sleeping in a quiet, cool, dark room.

  Irritable Bowel Syndrome

  An evaluation of research results by the American College of Gastroenterology concluded that relaxation techniques have not been shown to help irritable bowel syndrome. However, other psychological therapies, including cognitive-behavioral therapy and hypnotherapy, are associated with overall symptom improvement in people with irritable bowel syndrome.

  Menopause Symptoms

  Relaxation techniques have been studied for hot flashes and other symptoms associated with menopause, but the quality of the research isn't high enough to allow definite conclusions to be reached.

  Menstrual Cramps

  Some research suggests that relaxation techniques may be beneficial for menstrual cramps, but definite conclusions can't be reached because of the small number of participants in the studies and the poor quality of some of the research.

  Nausea

  An evaluation of the research evidence concluded that some relaxation techniques, including guided imagery and progressive muscle relaxation, are likely to be effective in relieving nausea caused by cancer chemotherapy when used in combination with anti-nausea drugs.

  Nightmares

  Pain

  Evaluations of the research evidence have found promising but not conclusive evidence that guided imagery may help relieve some musculoskeletal pain (pain involving the bones or muscles) and other types of pain.

  An analysis of data on hospitalized cancer patients showed that those who received integrative medicine therapies, such as guided imagery and relaxation response training, during their hospitalization had reductions in both pain and anxiety.

  Pain in Children and Adolescents

  A 2014 evaluation of the scientific evidence found that psychological therapies, which may include relaxation techniques as well as other approaches such as cognitive-behavioral therapy, can reduce pain in children and adolescents with chronic headaches or other types of chronic pain. The evidence is particularly promising for headaches: the effect on pain may last for several months after treatment, and the therapies also help to reduce anxiety.

  Posttraumatic Stress Disorder

  Studies of biofeedback and other relaxation techniques for posttraumatic stress disorder have had inconsistent results.

  Rheumatoid Arthritis

  There's limited evidence that biofeedback or other relaxation techniques might be valuable additions to treatment programs for rheumatoid arthritis.

  Ringing in the Ears (Tinnitus)

  Only a few studies have evaluated relaxation techniques for ringing in the ears. The limited evidence from these studies suggests that relaxation techniques might be useful, especially in reducing the intrusiveness of the problem.

  Smoking Cessation

  • Limited evidence suggests that guided imagery may be a valuable tool for people who are working to quit smoking.
  • In a study that compared the two techniques, autogenic training was found to be less effective than cognitive-behavioral therapy as a quit-smoking aid. However, this study involved patients in an alcohol detoxification program, so its results may not be applicable to other people.
  • Preliminary research suggests that a guided relaxation routine might help reduce cigarette cravings.

  Temporomandibular Joint Dysfunction

  Problems with the temporomandibular joint (the joint that connects the jaw to the side of the head) can cause pain and difficulty moving the jaw. A few studies have shown that programs that include relaxation techniques may help relieve symptoms of temporomandibular joint dysfunction.

  What the Science Says About the Safety and Side Effects of Relaxation Techniques

  • Relaxation techniques are generally considered safe for healthy people. However, occasionally, people report negative experiences such as increased anxiety, intrusive thoughts, or fear of losing control.
  • There have been rare reports that certain relaxation techniques might cause or worsen symptoms in people with epilepsy or certain psychiatric conditions, or with a history of abuse or trauma. People with heart disease should talk to their health care provider before doing progressive muscle relaxation.

  Who Teaches Relaxation Techniques?

  A variety of professionals, including physicians, psychologists, social workers, nurses, and complementary health practitioners, may teach relaxation techniques. Also, people sometimes learn the simpler relaxation techniques on their own.

Cochlear Implant : By Jaikumar Pareta

A severe to profound hearing loss in both ears prevents a person from understanding speech and communicating in everyday conversations. Cochlear implants can increase hearing and communication abilities for people who don’t receive enough benefit from traditional hearing aids.

Your elderly uncle is hard of hearing and has a difficult time understanding conversation — so much so that he’s feeling frustrated and left out. His hearing aids aren’t helping much.

Your one-year-old daughter was diagnosed with severe hearing loss in both ears, and you’re worried about her ability to learn and understand speech. How will she learn to communicate?

For both of these cases, a cochlear implant may be an option.

What are cochlear implants? Who uses them and why? And how does the U.S. Food and Drug Administration (FDA) play a role? The cochlea is the part of the inner ear that contains the endings of the nerve which carries sound to the brain. A cochlear implant is a small, electronic device that when surgically placed under the skin, stimulates the nerve endings in the cochlea to provide a sense of sound to a person who is profoundly deaf or severely hard of hearing.

How Does It Work?

A cochlear implant consists of an external part that sits behind the ear and an internal part that is surgically placed under the skin. Usually, a magnet holds the external system in place next to the implanted internal system. The FDA has approved cochlear implants for use by individuals aged one year and older.

Here’s how it works:

• A surgeon places the cochlear implant under the skin next to the ear.
• The 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 wearer experiences this as "hearing."

“A cochlear implant is quite different from a typical hearing aid, which simply amplifies sound,” says Nandkumar. “Using one is not just a matter of turning up the volume; the nerves are being electrically stimulated to send signals and the brain translates and does the rest of the work.” Moreover, cochlear implant wearers need to undergo intensive speech therapy to understand how to process what they are hearing.

Cochlear implants don’t restore normal hearing, says Nandkumar. But depending on the individual, they can help the wearer recognize words and better understand speech, including when using a telephone.

Does Age Matter?

 For young children who are deaf or severely hard-of-hearing, using a cochlear implant while they are young exposes them to sounds during an optimal period to develop speech and language skills. Several research studies have shown that when these children receive a cochlear implant at a relatively young age (for example, at 18 months) followed by intensive therapy, they tend to hear and speak better than those who receive implants at an older age.

But adults and older children who have acquired severe to profound hearing loss after they have acquired speech can also do very well with an implant, partly because they are post-lingual (that is, already have learned to speak a language). “At that point, a person has to get used to the fact that what he hears sounds differently and more ‘machine-like’ than it did when he had more hearing,” Nandkumar says. “Whereas someone who was profoundly deaf at birth will adapt at a very early age to a cochlear implant and the way in which it processes sound.”

Conversely, people who are deaf since birth and have not gotten implants until they are a bit older (for example, 8 years of age) may not derive as much benefit from cochlear implants.

FDA Regulation of Cochlear Implants

Before manufacturers can bring a new cochlear implant to market, they must submit studies and data to FDA scientists, who will review the information for safety and effectiveness. Cochlear implants are designated as Class III devices, meaning they receive the highest level of regulatory scrutiny. This is because they are surgically implanted near the brain, which increases health risk. Other risks, while minimal, include injury to the facial nerve, meningitis , perilymph fluid leak (fluid from the inner ear leaks through the hole created to place the implant), and dizziness or vertigo.

The Future of Cochlear Implants

Scientists continue to look for ways to improve cochlear implants and how they function once implanted. For example:

• Companies are developing more sophisticated strategies that help to minimize background noise and increase the noise-to-sound ratio, helping the user to better focus and understand speech.
• Hearing science researchers also are looking at the potential benefits of pairing a cochlear implant in one ear with either another cochlear implant or a hearing aid in the other ear.

“A cochlear implant won’t restore hearing the way that eyeglasses can fully restore vision,” Nandkumar says. “But companies are developing increasingly sophisticated processing strategies that can reduce background noise and increase the signal-to-noise ratio, in an effort to improve the quality of speech the wearer hears.”

Before, During, & After Implant Surgery

What happens before surgery?

Primary care doctors usually refer patients to ear, nose and throat doctors (ENT doctors or otolaryngologists) to test them to see if they are candidates for cochlear implants.

Tests often done are:

• examination of external, middle, and inner ear for signs of infection or abnormality
• various tests of hearing, such as an audiogram
• a trial of hearing aid use to assess its potential benefit
• exams to evaluate middle and inner ear structures
  • CT (computerized tomography) scan. This type of x-ray helps the doctor see if the cochlea has a normal shape. This scan is especially important if the patient has a history of meningitis because it helps see if there is new bone growth in the cochlea that could interfere with the insertion of the implant. This scan also may indicate which ear should be implanted.
  • MRI (magnetic resonance imaging) scan
• psychological examination to see if the patient can cope with the implant
• physical exam to prepare for general anesthesia

What happens during surgery?

The doctor or other hospital staff may:

• insert some intravenous (i.v.) lines
• shave or clean the scalp around the site of the implant
• attach cables, monitors and patches to the patient's skin to monitor vital signs
• put a mask on the patient's face to provide oxygen and anesthetic gas
• administer drugs through the i.v. and the face mask to cause sleep and general anesthesia
• awaken the patient in the operating room and take him or her to a recovery room until all the anesthesia is gone

What happens after surgery?

Immediately after waking, a patient may feel:

• pressure or discomfort over his (or her) implanted ear
• dizziness
• sick to the stomach (have nausea)
• disoriented or confused for a while
• a sore throat for a while from the breathing tube used during general anesthesia

Then, a patient can expect to:

• keep the bandages on for a while
• have the bandages be stained with some blood or fluid
• go home in about a day after surgery
• have stitches for a while
• get instructions about caring for the stitches, washing the head, showering, and general care and diet
• have an appointment in about a week to the stitches removed and have the implant site examined
• have the implant "turned on" (activated) about 3-6 weeks later

Can a patient hear immediately after the operation?

No. Without the external transmitter part of the implant a patient cannot hear. The clinic will give the patient the external components about a month after the implant surgery in the first programming session.

Why is it necessary to wait 3 to 6 weeks after the operation before receiving the external transmitter and sound processor?

The waiting period provides time for the operative incision to heal completely. This usually takes 3 to 6 weeks. After the swelling is gone, your clinician can do the first fitting and programming.

What happens during the initial programming session?

An audiologist adjusts the sound processor to fit the implanted patient, tests the patient to ensure that the adjustments are correct, determines what sounds the patient hears, and gives information on the proper care and use of the device.

Is it beneficial if a family member participates in the training program?

Yes! A family member should be included in the training program whenever possible to provide assistance. The family member should know how to manage the operations of the sound processor.

Do patients have more than one implant?

Usually, patients have only one ear implanted, though a few patients have implants in both ears.

How can I help my child receive the most benefit from their cochlear implant?

• try to make hearing and listening as interesting and fun as possible
• encourage your child to make noises
• talk about things you do as you do them
• Show your child that he or she can consciously use and evaluate the sounds he or she receives from his or her cochlear implant
• realize that the more committed you, your child's teachers, and your health professionals are to helping your child, the more successful he or she will be

What can I expect a cochlear implant to achieve in my child?

As a group, children are more adaptable and better able to learn than adults. Thus, they can benefit more from a cochlear implant. Significant hearing loss slows a child's ability to learn to talk and affects overall language development. The vocal quality and intelligibility of speech from children using cochlear implants seems to be better than from children who only have acoustic hearing aids.

How important is the active cooperation of the patient?

Extremely important. The patient's willingness to experience new acoustic sounds and cooperate in an auditory training program are critical to the degree of success with the implant. The duration and complexity of the training varies from patient to patient.

What are the Benefits of Cochlear Implants?

For people with implants:

• Hearing ranges from near normal ability to understand speech to no hearing benefit at all.
• Adults often benefit immediately and continue to improve for about 3 months after the initial tuning sessions. Then, although performance continues to improve, improvements are slower. Cochlear implant users' performances may continue to improve for several years.
• Children may improve at a slower pace. A lot of training is needed after implantation to help the child use the new 'hearing' he or she now experiences.
• Most perceive loud, medium and soft sounds. People report that they can perceive different types of sounds, such as footsteps, slamming of doors, sounds of engines, ringing of the telephone, barking of dogs, whistling of the tea kettle, rustling of leaves, the sound of a light switch being switched on and off, and so on.
• Many understand speech without lip-reading. However, even if this is not possible, using the implant helps lip-reading.
• Many can make telephone calls and understand familiar voices over the telephone. Some good performers can make normal telephone calls and even understand an unfamiliar speaker. However, not all people who have implants are able to use the phone.
• Many can watch TV more easily, especially when they can also see the speaker's face. However, listening to the radio is often more difficult as there are no visual cues available.
• Some can enjoy music. Some enjoy the sound of certain instruments (piano or guitar, for example) and certain voices. Others do not hear well enough to enjoy music.

What are the Risks of Cochlear Implants?

General Anesthesia Risks

• General anesthesia is drug-induced sleep. The drugs, such as anesthetic gases and injected drugs, may affect people differently. For most people, the risk of general anesthesia is very low. However, for some people with certain medical conditions, it is more risky.

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, see the nearby Useful Links.
• Cerebrospinal fluid leakage --the brain is surrounded by fluid that may leak from a hole created in the inner ear or elsewhere from a hole in the covering of the brain as a result of the surgical procedure.
• Perilymph fluid leak --the inner ear or cochlea contains fluid. This fluid can leak through the hole that was created to place the implant.
• Infection of the skin wound.
• Blood or fluid collection at the site of surgery.
• Attacks of dizziness or vertigo.
• Tinnitus, which is a ringing or buzzing sound in the ear.
• Taste disturbances --the nerve that gives taste sensation to the tongue also goes through the middle ear and might be injured during the surgery.
• Numbness around the ear.
• Reparative granuloma --this is the result of localized inflammation that can occur if the body rejects the implant.
• There may be other unforeseen complications that could occur with long term implantation that we cannot now predict.

Other Risks Associated with the Use of Cochlear Implants

People with a cochlear implant:

• May hear sounds differently. Sound impressions from an implant differ from normal hearing, according to people who could hear before they became deaf. At first, users describe the sound as "mechanical", "technical", or "synthetic". This perception changes over time, and most users do not notice this artificial sound quality after a few weeks of cochlear implant use.
• May lose residual hearing. The implant may destroy any remaining hearing in the implanted ear.
• May have unknown and uncertain effects. The cochlear implant stimulates the nerves directly with electrical currents. Although this stimulation appears to be safe, the long term effect of these electrical currents on the nerves is unknown.
• May not hear as well as others who have had successful outcomes with their implants.
• May not be able to understand language well. There is no test a person can take before surgery that will predict how well he or she will understand language after surgery.
• May have to have it removed temporarily or permanently if an infection develops after the implant surgery. However, this is a rare complication.
• May have their implant fail. In this situation, a person with an implant would need to have additional surgery to resolve this problem and would be exposed to the risks of surgery again.
• May not be able to upgrade their implant when new external components become available. Implanted parts are usually compatible with improved external parts. That way, as advances in technology develop, one can upgrade his or her implant by changing only its external parts. In some cases, though, this won't work and the implant will need changing.
• May not be able to have some medical examinations and treatments. These treatments include:
  • MRI imaging. MRI is becoming a more routine diagnostic method for early detection of medical problems. Even being close to an MRI imaging unit will be dangerous because it may dislodge the implant or demagnetize its internal magnet. FDA has approved some implants, however, for some types of MRI studies done under controlled conditions.
  • neurostimulation.
  • electrical surgery.
  • electroconvulsive therapy.
  • ionic radiation therapy.
• Will depend on batteries for hearing. For some devices new or recharged batteries are needed every day.
• May damage their implant. Contact sports, automobile accidents, slips and falls, or other impacts near the ear can damage the implant. This may mean needing a new implant and more surgery. It is unknown whether a new implant would work as well as the old one.
• May find them expensive. Replacing damaged or lost parts may be expensive.
• Will have to use it for the rest of life. During a person's lifetime, the manufacturer of the cochlear implant could go out of business. Whether a person will be able to get replacement parts or other customer service in the future is uncertain.
• May have lifestyle changes because their implant will interact with the electronic environment. An implant may
  • set off theft detection systems
  • set off metal detectors or other security systems
  • be affected by cellular phone users or other radio transmitters
  • have to be turned off during take offs and landings in aircraft
  • interact in unpredictable ways with other computer systems
• Will have to be careful of static electricity. Static electricity may temporarily or permanently damage a cochlear implant. It may be good practice to remove the processor and headset before contact with static generating materials such as children's plastic play equipment, TV screens, computer monitors, or synthetic fabric. For more details regarding how to deal with static electricity, contact the manufacturer or implant center.
• Have less ability to hear both soft sounds and loud sounds without changing the sensitivity of the implant. The sensitivity of normal hearing is adjusted continuously by the brain, but the design of cochlear implants requires that a person manually change sensitivity setting of the device as the sound environment changes.
• May develop irritation where the external part rubs on the skin and have to remove it for a while.
• Can't let the external parts get wet. Damage from water may be expensive to repair and the person may be without hearing until the implant is repaired. Thus, the person will need to remove the external parts of the device when bathing, showering, swimming, or participating in water sports.
• May hear strange sounds caused by its interaction with magnetic fields, like those near airport passenger screening machines. 
• SUMMARY:

• What is a cochlear implant?

  

  Ear with 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.