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COCHLEAR IMPLANT PROGRAM
Surgical Information


Description of Device

The cochlear implant consists of a device that will be placed under the skin and into the mastoid cavity behind the ear during the surgical procedure. The electrode array is the part of the internal component that is placed into the cochlea (the inner ear-portion responsible for hearing). With the devices used at Henry Ford Health System you will have 12 or 22 stimulating electrodes (the MedEl or the Cochlear Nucleus device respectively-note having 12 or 22 does not change the outcome, it is just a different design). There is the possibility that you will be able to feel the device behind your ear. This bumpy area may become more noticeable over time, particularly following the decrease of swelling post surgery.

You will also have to wear an external processor. There are several components to the external piece. These include a microphone, which receives the acoustic signal and sends it to the processor. The processor changes the acoustic signal to an electric signal so the electrodes can be stimulated. The electric signal is sent to the coil, which sends the information to the internal component via radio frequency transmission.

The external processor may be a body-level device that can be worn in a pocket, on the waistband, or on a belt. Or, the external portion may be worn behind the ear, and ear level device.

Candidacy

A cochlear implant is designed to provide hearing information to severely and profoundly hearing impaired individuals whose ability to understand speech with a hearing aid is severely restricted. In general, a candidate must be oral and have very little reliance on sign language as a mode of communication. There must not be any medical contraindications, which will be assessed by the surgeon. Persons wishing to pursue a cochlear implant must be very motivated due to the rigorous rehabilitation that is necessary for success. Cochlear implant users must have a strong support system between their family and friends, as well. A candidate must have appropriate expectations, some of which are listed below.

  • Speechreading will always be an integral part of a candidate's life. Although understanding of speech may be possible with the implant alone, it is designed for use in conjunction with speechreading to improve overall communication ability.
  • A cochlear implant recipient should be able to hear as soon as the processor is hooked-up; however, it will take time for the person to understand through the implant.
  • The telephone will be difficult to use because speechreading cannot be utilized.
  • The auditory signal will not sound the same as remembered. Cochlear implant patients have described the new sound as that of a cartoon character (Mickey Mouse, Donald Duck, Charlie Brown, Darth Vader, robotic, etc).
  • Music may not sound the same either. Many people do not like the sound of music through their implants.
  • There is a stringent rehabilitation schedule, which is attached.
  • A considerable time commitment is necessary as well. Each individual must practice listening through his or her cochlear implant regularly.
  • If you have significant skin issues ie seborrhea, psoriasis or eczema, it can be a relative contraindication to surgery as we cannot afford to have a skin infection at the site of the implant.
  • You must have realistic expectations and understand the fact that the implant may not function the way that you had hoped.
  • Currently, there is a mandatory requirement that all potential CI patients be evaluated by a counselor, psychologist, psychiatrist etc. This helps to verify that the motivation is appropriate and that you will be committed to the necessary work required to have a successful outcome. The entire procedure and device costs ~ 50-60,000.00, so no one wants to misuse precious resources on an individual who decides that they don't like the implant.
  • You will be evaluated by an Otolaryngologist to determine your overall CI candidacy
  • You must have a hearing test documenting the hearing loss
  • You must have a high resolution computed tomographic scan (CT) to verify that your cochlea is formed normally enough to accept the electrode array. Some patients with a previous history of meningitis or other disorders, may have a cochlear duct that is overgrown with bone and sometimes this makes an implant procedure impossible.
  • Rarely, you may be required to undergo a test called "Promontory Stimulation". This is where an electrode is placed on your eardrum or through your eardrum (after numbing the ear) on to the promontory to assess the viability of your hearing nerve. This is not a test that we depend upon completely as some patients with poor promontory stimulation are excellent CI users and others with good promontory stimulation tests are poor users.

Risks of surgery

1.Bleeding and infection are inherent risks with any surgical procedure. These can be life and or device threatening, but thankfully are rare (usually less than 1%, I have never had a patient require a blood transfusion for this procedure, but theoretically it is possible).

2.Any operation on the ear or mastoid region have specific inherent risks which can be short term or permanent these include but are not limited to:
a)Change or loss of sense of taste (the device goes between the taste and facial nerves)
b)Facial weakness or paralysis
c)Dizziness and disequilibrium are common after this procedure as we enter the inner ear {the inner ear consists of both the cochlear (hearing portion of the inner ear) and the vestibular system (balance portion of the inner ear)}. About 50% of patients will feel this way for 1-6 weeks. (Not really a complication unless it is permanent)
d)No improvement in the hearing perception, it is possible though rare that you will have no benefit from the device.
e)Tinnitus (ringing in the ear). Many patients already have this symptom prior to the implant and often the tinnitus is improved while the implant is on. Some patients report improvement, worsening or no change in their tinnitus.
f)Complete loss of all residual hearing-this occurs in nearly all cases. Thus once the implant is done, if you had perceived any benefit from the hearing aid before surgery it is highly unlikely that you will have ANY residual hearing. (This is not a complication, but a known outcome of the surgery).
g)Stimulation of other nearby cranial nerves. There are nerves that can be indirectly electrically stimulated by the implant. These include the facial nerve (would manifest as facial twitching while the implant is on), the nerves for swallowing, voice and shoulder movement can all be unintentionally stimulated. This can cause throat discomfort or pain, jumping of the shoulder for example. This complication is rare but it can be a nuisance if it does occur.
h)Extrusion of the implant. Rarely the device can come out of the cochlea and become unusable. This would necessitate the re-insertion of the device.
i)Extrusion of the implant from the skin. This is a significant complication which has been reported in as many as 5% of the cases, in my experience this is very rare, but possible. You must be sure to keep the wound clean and it helps to not have the magnet too tight as this can also cause skin breakdown. This tends to be more common in females as their scalp tends to be thinner than males.
j)Implant placed in the wrong position. This is also rare but possible; the two most common areas for the implant to go (in the wrong position) is into the hypotympanum (the area below the cochlea) or into the semi-circular canal. Both of these complications can and do occur, rarely, but would require a second procedure to attempt to replace into the correct position.
k)Meningitis (more info below)
l)Cerebrospinal fluid leak. This is rare but in order to seat the device into a lower profile position it is sometimes necessary to remove bone over the dura (covering of the brain). A small hole can be made in the dura when using sutures to secure the device into place and then CSF would leak out. If fluid can leak out, infection can go in and cause meningitis.
m)Brain abscess (very rare)
n)Death (very rare), usually a complication of general anesthesia ~ 5/1,000,000.

3.Device issues from the internal component:
a.A small lump (common) may be felt behind the ear. As described above, this is the internal device, which can be felt through the skin.
b.Possible irritation, inflammation, or breakdown of the skin in the area over the implanted device. If any of these occur, the patient should be seen by the surgeon for possible medical treatment.
c.The internal device may fail. Failure rates of cochlear implants are extremely low; however, it is a man-made device and can malfunction. In such cases, the failed device can be removed and a new device put in its place.
d.You may lose any hearing that you may still have in the implanted ear.
e.The long-term effects of electrical stimulation like that produced by the implant are unknown.

I understand and accept the possibility of the aforementioned risks _______.

Further issues concerning meningitis

Notification from the FDA (July 24, 2002):

"The FDA has become aware of the possible association between cochlear implants and the occurrence of bacterial meningitis . . . The onset of meningitis symptoms ranged from less than 24 hours to greater than 5 years from time of implant."

"Meningitis is an infection of the lining of the surface of the brain. Early symptoms of meningitis include fever, irritability, lethargy and loss of appetite in infants and young children. Older children and adults may also manifest headache, still neck, nausea and vomiting, and confusion or alteration in consciousness, photophobia (light bother eyes). . . .The younger patient population (<2 yrs) and the elderly are most vulnerable to meningitis."

"Cochlear implant candidates, as well as those already implanted, may benefit from vaccinations against organisms that commonly cause bacterial meningitis, particularly Streptococcus pneumoniae and Haemophilus influenzae."

a.The implant companies that we use here at Henry Ford Health System has a rate of meningitis in its recipients that is less than or equal to that of the general population. However, we advise, in accordance with the FDA that individuals receive the following immunizations prior to cochlear implantation:
S. pneumoniae
< 2 years old Prevnar
2 – 5 years oldPrevnar + Pneumovax
> 5 years oldPneumovax
H. influenza
< 5 years old

I understand and accept the possibility of the aforementioned risk _____.

4.Those involving postoperative limitations imposed by the devices:
a.Contact sports or sports that have a high likelihood of causing significant jarring to the head should be discouraged. A blow to the head can damage the internal device. Activities that present significant risk of falls (i.e. rollerblading, bicycling, contact sports) should be entered into with adequate precaution, including the use of protective headgear.
b.The audiologist cannot program the speech processor without you. Active involvement by the patient is crucial in the process.
c.Appropriate fit of the magnet is important. Increasing the magnetic pull by screwing the magnet in closer to the head or using too strong of a magnet can put pressure on the implant site that can lead to skin breakdown. If tenderness or pain is noted under the receiver (the coil), contact an implant audiologist immediately.
d.The speech processor has a warranty; however, once it expires, any repair or replacement costs will be the responsibility of the patient. The cochlear implant company chosen by the patient may have an extended service plan, and should be purchased.
e.Activities in which static electricity may be generated (i.e. sliding down plastic slides, playing in plastic balls, contact with computer monitors, or dry cold weather) have on rate occasions caused damage to the internal portion of the device. Static electricity can also erase the maps inside the speech processor. NOTE: Do not change batteries in front of the computer.
f.Any activity that alerts users of medical devices to the presence of electromagnetic fields should be avoided.
g.Internal cochlear implant components do not usually set off metal detectors. Airport security will not damage the internal component. However, it is best to remove the external device and passit around the security checkpoint. There is a chance that the map(s) on the processor could be corrupted. Carry your CI ID card OR get a letter from the implant team before traveling.

I understand and accept the possibility of the aforementioned risks ______.

All cochlear implant systems are designed so that there is minimal risk to the patient. The internal component does not have a power source. Removal of the external device will immediately result in shutdown of the internal device activity. If there is any doubt about the device function, remove the external portion from the head and contact an implant audiologist.

Benefits from the cochlear implant

1.The cochlear implant system, when used in conjunction with speechreading, should improve your communication abilities.
2.With the cochlear implant you should be able to hear environmental sounds that you were unable to hear with your hearing aid (most patients).
3.Many, but not all, implant users can understand some speech with no visual cues, and many, but not all, implant users can understand some speech over the telephone.
4.The worst "performers" will hear nothing with the implant (very rare-less than 5%). Poor performers can tell the difference between a train and a door slamming (for example-~ 5%). Excellent performers can hear most everything, don't require lip reading or sign language and talk on the phone (~10%).

What to expect regarding the week before and the day of surgery

Approximately one week before surgery, you will be evaluated by a member of the anesthesia team. They will take additional relevant history related to your health and anesthetic risks and concerns. They may or may not require, additional testing such as blood work, chest x-ray and an EKG (this depends upon age, health and social and lifestyle choices).

If you are a smoker, it would be terrific if you could quit. This will lower anesthetic risks and improve your healing.

You must discontinue all aspirin or motrin containing compounds two weeks before surgery. Additionally, if you take other blood thinners, ie lovinox, heparin, coumadin these will have to be discontinued by working with your primary care physician and the anesthesia team. If you take nutritional supplements, you must disclose the ingredients as many things such as vitamin E, gingko, ginseng, garlic and ginger (there are many more) can affect your bleeding and other herbs like St John's Wort, Valerian root etc can affect your anesthetic medications.

You must have nothing to eat or drink after midnight the night before surgery. It is imperative that your stomach is empty. The anesthesia team will usually allow you to take your medications with a SMALL sip of water, but you must verify this with them first.

Once you have come to the hospital the day of surgery, they will do any additional necessary paperwork and escort you to the preoperative area, I will usually meet you there and reconfirm the procedure, the side that we are operating on and will answer any other questions you might have.

Once you leave the pre-operative area, you will be taken to the operating room, where the anesthesia team will apply appropriate devices to monitor your heart, oxygenation, temperature and other vital signs to insure your safety while you are asleep. Once you are asleep, me or my team members will place a facial nerve monitor (goes around your cheek area) and other necessary probes. A safe amount of hair is trimmed with an electric razor to reduce the risk of infection (I say it is a small amount, all my patients think it is too much!). You will also receive intravenous antibiotics (given in the pre-operative or operating room).

The surgical procedure takes ~ 1.5-2 hours to complete. Special testing of the device is performed before the wound is closed to verify proper function of the device. There is approximately 30 min of additional time (coming into the room, putting monitors on etc) and another 30 minutes after the surgery is completed to (wake you up, remove monitors, put on a head dressing etc). Thus, from the time you leave the preoperative area to the time you arrive in the recovery room it is about 3-4 hours of time.

You will be in the recovery room a safe amount of time as determined by the anesthesia team. If you are quick this might be as short as 45 minutes and if you recover more slowly it may be 3-5 hours; every patient is different. In rare situations we would keep you overnight (<1% of the time).

You will be sent home with pain medication and an antibiotic, the latter needs to be taken for one week. 24 hours after surgery you should cut the head bandage off (cut the bandage near the middle of your forehead-be careful). There will usually be some blood on the bandage, some patients have a little some have a lot.

Everybody has a different pain tolerance, some patients use only plain Tylenol after surgery for 1-2 days while others require prescription strength pain medication for a week. All spectrums are normal.

There will be some "steri-strips" (like strips of a bandaid) behind your ear. You can remove these in one week or we will do it for you in the office, whichever you prefer. You can remove quickly (usually the best way-just like a bandaid). Some patients prefer to gently moisten the strips with peroxide, feel free to do this prior to peeling it off.

All of the sutures (stitches) are under your skin, except usually there are 2-3 small absorbable stitches on the skin, these will dissolve in 2-4 weeks. If they are bothering you, I can snip them in the office.

You will need to schedule a postoperative visit at one week. This is usually done by the Physician Assistant that works with me (just to be sure that the wound looks good). The CI is usually activated between 6-8 weeks after surgery, this is determined by the surgeon and the audiologist (standard is eight weeks). I will need to see you (personally) ~ 2-3 weeks after you have had your CI activated.

Some do's and don'ts

1.Keep the wound clean, while the strips are on you really do not have to do anything to the wound.
2.The wound must remain dry for one week.
3.You may shower from your neck down, wash your face with a washcloth and try not to splash water near the surgical site.
4.To wash your hair, you can either do it in the sink (keeping your surgical site dry) or use the powder shampoo (can get this at camping stores). Some patients will wash their hair in the shower. They do this by covering the wound with plastic (like saran wrap) or a couple of compacted dry washcloths. Note a tiny amount of water on the wound will not hurt it, but it is recommended to keep it dry.
5.There will be bruising, some patients bruise, with a black eye, down their neck to the opposite side and to their chest (rare, but more common in older patients) and others have no bruising.
6.No strenuous activity: No lifting, bending or straining for three weeks.
7.You may return to work 48 hours after surgery provided that you feel okay and that you are not to dizzy. If you work in a dusty or dirty environment or if you do manual labor, you will need 1-2 weeks off after surgery, possibly longer.
8.You may drive 24 hours after surgery provided that your balance is normal and that you are not having any dizziness.

Alternatives to cochlear implantation

1.Continue the use of power hearing aids.
2.Use of a vibrotactile device, which will alert one to sound using vibration.
3.Attendance in speechreading classes, which teach people to communicate visually more effectively.
4.Learn sign language, and make use of a sign language interpreter.

Please notify my office if you have:

1.A temperature above 100.5 degrees Fahrenheit
2.Excessive bleeding (soaking through the bandage despite reinforcing it with additional gauze)
3.Excessive pain (ie pain not relieved by the pain medication-will still likely have pain, but it should not be unbearable)
4.Some patients will have significant nausea and even vomiting, if it does not settle down within 24 hours please contact us.
5.Clear nasal drainage from the same side the surgery was on (this could signify a CSF leak)
6.If you have any questions or concerns please feel free to contact me.

I just want you to know that I realize that this is a big step for you, and I am convinced that you will do just fine. It is normal to be anxious, but try to keep this all in perspective, get a good nights sleep and think positively.

Thank you for the privilege of caring for you, I am here to help you. I will provide you with the best possible medical, surgical and compassionate care possible.

Michael D. Seidman, MD., FACS
Henry Ford Health System
Director Division of Otologic/Neurotologic surgery
Medical Director Center for Complementary/Integrative medicine
6777 W. Maple Rd
W. Bloomfield, MI 48323

Office: 248-661-7211
Pager: 313-714-4150

Email: mseidma1@hfhs.org

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