Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults
Phase: NA
Conditions: Hearing Loss
Sponsor: Cochlear

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Page 1 of 17 
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults 
Informed Consent Version 1.0 
RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear 
Implant in Adults 
Instructions to the Investigator: 
The investigator must obtain informed consent prior to performing any study 
procedures.  The investigator should keep the original signed consent form, 
and the subject should be given a copy of the signed document. 
Instructions to Potential Subjects: 
Please read this consent form carefully.  It contains important information to 
help you decide whether to participate in a research study.  The study staff 
will explain this study to you.  Ask questions about anything that is not clear at 
any time.  You may take home an unsigned copy of this consent form to think 
about or discuss with family or friends before making your decision. 
This consent form may contain words that you do not understand.  Please ask 
the investigator or the study staff to explain any words or information that you 
do not clearly understand.  If you have questions about the research, please 
consult your doctor or audiologist. 
Subject Participation 
1. This study involves both inpatient and outpatient care. 
2. The Sponsor of this study is Cochlear Americas. 
3. The Sponsor plans to enroll a total of up to 55 adult subjects (aged 18 
or older) across up to 20 cochlear implant centers in the United States. 
4. If you qualify for the study and agree to its requirements, you or your 
insurance company will be billed for the same cost of a standard 
Cochlear Nucleus cochlear implant system that would be charged if 
you were not enrolled in a study. 
5. Enrollment into the clinical trial is based upon your candidacy 
evaluation.  You will not be enrolled into the study until that evaluation 
is complete and shows that you are a good candidate. 
6. Before you can start the study, the study doctor or study staff will talk 
to you about the study.  Then you have to sign this consent form 
before the study doctor or study staff can begin to see if you qualify to 
be in the study.  After you sign this form, the study doctor or study staff 
will do the things listed below when you come in for study visits.  If you 
would like more information about which tests and procedures will be 
done at each study visit, ask the study doctor or study staff.  Your 
signature on this Consent Form indicates that you agree to participate 
in the study entitled “Safety and Efficacy of the Cochlear Nucleus 
CI422 Cochlear Implant in Adults.” 

Page 2 of 17 
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults 
Informed Consent Version 1.0 
7. Participation requires coming in for up to 2 study visits before the 
implant surgery, and 4 study visits after the surgery, each of which will 
take 2 to 5 hours.  These study visits will occur across approximately 
14 to 16 months.  The last visit will occur 12 months after your cochlear 
implant is activated.  Your surgeon or audiologist may require 
additional follow-up visits as part of your routine care. 
8. Cochlear implant device programming and audiology testing will be 
repeated a number of times during the study visits.  You may become 
tired or bored during these sessions.  In order to minimize fatigue, 
frequent breaks will be offered during the test sessions and/or a test 
session may be spread across 2 days rather than 1 day. 
During the study: 
1. You will be evaluated to make sure you are a candidate for the study.  
Your surgeon will discuss your medical history with you and perform a 
physical exam.  X-rays may be taken of your inner ear(s).  
2. You will need to be a bilateral hearing aid user (wear a hearing aid in 
both ears).  You will be required to have a minimum of 30 days 
experience with well fit hearing aids prior to being accepted into the 
study.  If you already have hearing aids, your audiologist will do a test 
to make sure they are fit according to a prescription based on your 
hearing loss.  If this test determines that you have been using hearing 
aids that are not appropriately fit or well-functioning, or you do not own 
hearing aids, you will need to undergo a minimum 30 day trial period 
with hearing aids fit to your prescription.  Loaner hearing aids may be 
made available before surgery for trial purposes if you do not use 
hearing aids or need new hearing aids.  However, you will be 
responsible for the cost associated with the fitting of a hearing aid in 
your nonimplanted ear, if warranted, after surgery.  The hearing aid 
trial, if required, would involve 1 or 2 additional visits to your cochlear 
implant center. 
3. You will need to be willing to use the cochlear implant on one ear and 
a hearing aid on the opposite ear for at least 6-months following 
implant activation. 
4. Your audiologist will give you a number of hearing and speech tests 
both with and without hearing aids.  These tests will include measuring 
your ability to hear tones, and to understand speech in each ear.  If it is 
determined that you are a good candidate, your audiologist will do 
additional testing.  The first evaluation may last up to 5 hours, and may 
be done over 1 or 2 days. 
5. Before the cochlear implant surgery, you should discuss the risk of 
meningitis with your surgeon, and obtain any recommended 
vaccinations.  The Centers for Disease Control (CDC) recommends 
that persons planning to receive a cochlear implant should be up-to-

Page 3 of 17 
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults 
Informed Consent Version 1.0 
date on age-appropriate pneumococcal vaccination ≥2 weeks before 
surgery, if possible.  (More information about the CDC’s 
recommendations can be found at http://www.cdc.gov/mmwr/preview/ 
mmwrhtml/m2e731a1.htm or by calling the CDC’s National 
Immunization Information Hotline at 1-800-232-2522). 
6. You will receive a cochlear implant system.  A cochlear implant has 
two parts: an internal part called the implant, and an external part 
called the speech processor.  You cannot see the internal part 
because it is under the skin.  The speech processor sits behind the ear 
similar to a hearing aid. 
7. You will undergo cochlear implant surgery.  Cochlear implant surgery 
requires general anesthesia (going to “sleep”).  This surgery normally 
takes 2 to 3 hours.  During surgery, your scalp may need to be shaved 
around the site of the implant.  The surgeon will make an incision (cut) 
behind your ear, create a pocket in the bone for placing the implant, 
and thread an electrode array (a very small, thin “tube” of silicone 
rubber with 22 metal contacts) into the inner ear.  Then the incision is 
closed.  The length of the hospital stay will be determined by your 
surgeon.  Typically, implant patients go home later the same day or 
early the following morning.  Most people return to normal activities 
within a few days or a week.  As with any surgery, there may be some 
discomfort.  Most discomfort or pain after the operation can be 
managed with standard pain-killing medicine. 
If you have questions regarding the surgery, it is important that you 
discuss them with your surgeon or cochlear implant team before you 
sign this form. 
8. You will be required to wear a hearing aid in the unimplanted ear after 
surgery, in addition to the cochlear implant system, for a period of at 
least 6 months.  However, if a new hearing aid is required to provide 
appropriate amplification for the unimplanted ear after surgery, the cost 
of the hearing aid will be your responsibility. 
9. You will return to your cochlear implant center for activation of the 
cochlear implant system by your audiologist following a healing period 
(typically 2-to-6 weeks).  The length of the healing period will be 
determined by your surgeon.  You will be fitted with a Cochlear™ 
Nucleus® 6 sound processor (CP900 series).  You will be instructed on 
the system’s use and care. 
10. You will be required to complete the next 3 sessions within an 
acceptable time frame based on this initial activation date.  Each 
appointment will be referenced to this date and must not be more than 
30 days outside of the specified interval.  That means that the “3-
month postactivation” appointment must be done 2 to 4 months after 
the initial activation appointment, the “6 month” appointment must be 
within 5 to 7 months after the initial activation appointment, etc.  It is 

Page 4 of 17 
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults 
Informed Consent Version 1.0 
very important that you come to all the appointments during the course 
of the study. 
11. At the study visits, before and after the surgery, you will participate in 
routine hearing testing and speech understanding tests in quiet and 
when there is background noise.  At some appointments you will also 
be asked to listen for differences in music tones.  These visits will each 
last between 2 and 5 hours. 
12. Finally, you will be asked to complete study questionnaires about how 
the cochlear implant has affected your health and ability to hear in 
everyday life situations. 
Reimbursement and Costs 
Being in this study is voluntary.  Cochlear will pay you $12.50 per hour for 
each study visit.  The number of hours paid will be based on the amount of 
time you will spend per session.  It will include these measurement sessions: 
candidacy, baseline, initial activation, 3 months, 6 months, and 12 months 
postactivation.  The Sponsor will pay for your meals during your day of 
testing.  With prior approval, the Sponsor will pay for an overnight hotel stay if 
you live more than 2 hours away from the clinic for test sessions that will take 
more than 2 hours to complete, if required.  If you would like to receive 
payment for your participation, you will need to complete a W-9 form that 
reveals your name and social security information.  A W-9 is required 
because study payments for your time are taxable.  This does not apply to 
payments made to you as reimbursement for meals or any hotel stays.  
Lastly, you are responsible for, and will have to pay for, transportation to and 
from your clinic for study visits. 
If you agree to participate in this study, please understand that you and/or 
your insurance company will be billed for a Nucleus cochlear implant system 
and for surgery.  You or your insurance company will be billed for any 
medical, surgical, or audiology treatment that you might need after receiving 
the cochlear implant.  Cochlear Americas will not pay you for any audiology or 
medical evaluation conducted before or after surgery.  You will not be 
reimbursed by Cochlear Americas for the surgery, programming of the device, 
or any therapy you receive.  These services are all standard components of 
learning to hear with a cochlear implant. 
Where possible, your own existing hearing aids will be used during the study.  
However, as stated above, if a new hearing aid is required to provide 
appropriate amplification for the unimplanted ear after surgery, the cost of the 
hearing aid will be your responsibility. 
It is important that you check with your insurance company about payment for 
the cochlear implant surgery.  It is possible that your insurance company may 
not pay for a cochlear implant because you have better hearing than most 
current implant candidates.  If your insurance company does not agree to pay 
for the cochlear implant, you will be billed for the surgery whether or not you 

Page 5 of 17 
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults 
Informed Consent Version 1.0 
choose to participate in this study. 
Purpose and Background 
This study involves research.  The main purpose of this research is to 
assess whether the CI422 cochlear implant is safe and effective in people 
who may have more hearing than current cochlear implant candidates. 
The CI422 cochlear implant device was approved on March 26, 2012 by 
the Food and Drug Administration (FDA) for people who have less hearing 
than you do.  At this time, cochlear implants are not commonly used for 
people with your type of hearing loss.  You are being asked to participate 
in this research study because, based on positive results in early studies, 
the Sponsor believes the Cochlear Nucleus CI422 cochlear implant should 
be studied in more people with hearing loss like yours. 
The devices to be used in this study include: 
 The Cochlear Nucleus CI422 cochlear implant.  The Cochlear Nucleus 
CI422 cochlear implant is different from previous commercial cochlear 
implants in that it has a newly designed thin, straight electrode array.  
The thinner electrode array design is intended to help preserve the 
delicate structures in the cochlea. 
 The Nucleus 6 (CP900 series) sound processor (a mini “computer” that 
picks up sound with a microphone and converts those sounds into an 
electric signal). 
 An acoustic component, which consists of a mini speaker built into a 
soft dome earpiece that will fit in your ear.  The acoustic component is 
connected to the sound processor and delivers amplified sound to your 
ear in the same way that a hearing aid does.  This component will be 
used in combination with the sound processor if any low pitch hearing 
is present after your cochlear implant surgery. 
The sponsor expects that you will lose some or all residual hearing in the 
implanted ear at the time of cochlear implantation.  The sound processor will 
be adjusted to match your hearing profile after surgery. 
In summary, this study will look at whether or not the CI422 cochlear 
implant works as well or better than a hearing aid for providing speech 
understanding to people with your type of hearing loss. 
Possible Benefits from the Research 
The Cochlear Nucleus CI422 cochlear implant with Cochlear Nucleus 6 
sound processor system may improve your understanding of speech in 
quiet and in noise.  The implant also may enable you to hear sounds in 
your environment better than you do now. 
If any low pitch hearing is present after your surgery, the combination of low-
pitched acoustic (via amplification) and high-pitched electric hearing from the 
cochlear implant may provide you with additional speech understanding in 

Page 6 of 17 
Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults 
Informed Consent Version 1.0 
quiet and noise.  It is also possible that the addition of acoustic hearing from 
the other ear (via a hearing aid) will provide further benefit. 
The information gained from your participation in the study will provide 
useful information to Cochlear Americas, the distributor of the device, 
which may benefit future cochlear implant recipients with hearing loss like 
yours. 
It is important to understand that these are possible benefits.  There is no 
way to know for sure that you will have these or any benefits from the 
cochlear implant.  It is possible that there may be no benefit to you from 
joining this study. 
Possible Risks from the Research 
Risks Associated with All Surgery 
a) Risks associated with ALL surgery include the possibility of pain, 
scarring, bleeding and infection after surgery. 
b) The use of anesthesia has inherent risks to the heart, lungs, kidneys, 
liver and brain and, in rare cases, can result in death. 
Risks Associated with All Ear Surgery 
a) Risks associated with ALL ear surgery include potential damage to the facial 
nerve and dizziness.  This procedure may result in infection or bleeding, or 
numbness or stiffness about the ear.  Taste disturbance, increased tinnitus, 
neck pain, skin reactions, and leakage of inner ear fluid are possible risks.  
Facial nerve monitoring will be performed during the implant surgery.  Before 
your surgery, your ear surgeon and anesthesiologist will discuss with you the 
risks of cochlear implant surgery. 
 
b) Meningitis is a known risk of inner ear surgery.  Meningitis is an infection.  
The infection is in the fluid and tissue that surrounds the brain and spinal 
cord.  There are two main types of meningitis, viral and bacterial.  Bacterial 
meningitis is the most serious type.  It is the type that has been reported to 
occur in some people with cochlear implants.  Certain conditions may 
increase the risk of meningitis.  These conditions include congenital ear 
malformations, the presence of a cerebral spinal fluid (CSF) shunt or drain, 
recurrent episodes of bacterial meningitis prior to cochlear implant surgery, 
the presence of a perilymphatic fistula, and some types of skull fractures and 
defects. 
Risks Associated With All Cochlear Implant Surgeries 
Risks associated with implantation of the internal receiver-stimulator and 
cochlear electrode array include: 
a) Failure of parts of the implanted device could result in removal, replacement 
of the implant, or a reduction of the number of electrodes in use.  The risk of 
removing a failed implant, if necessary, is thought to be small.  An implant 

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may be removed and replaced with another device.  
b) Failure of the operation, perhaps requiring removal of the implant. 
c) Irritation, redness or breakdown of the skin in the area around the receiver-
stimulator and /or rejection of the device.  The electrode array may migrate 
(move) partially, resulting in decreased hearing ability.  The electrode array 
may perforate structures of the external or middle ear, such as the eardrum or 
canal wall.  Misplacement of the electrode may result in nonauditory 
sensations.  Such complications may require additional medical treatment, 
surgery and/or removal of the device. 
d) Increased tinnitus or facial nerve stimulation due to the electrical stimulation 
of the implant.  This could also cause dizziness or pain. 
e) Component failure may reduce the number of electrodes available for 
programming and may result in the perception of uncomfortably loud sounds 
or no sound. 
f) Loss of any remaining hearing in the ear that will receive the cochlear implant. 
Please see Appendix A of this form for the full list of warnings for people who 
receive a cochlear implant. 
Risks Specifically Associated With This Trial 
You will likely lose at least some hearing in the ear that is implanted.  It is 
possible that you will lose all hearing in this ear.  Even if you do not lose 
hearing right after surgery, it is possible that there could be a gradual or 
sudden hearing loss at any time.  If you notice any change to your hearing, 
even if you believe that it is related to your hearing aid or sound processor, it 
is important that you seek immediate medical attention to assess whether 
treatment is needed. 
It is important to understand that a loss of residual hearing is permanent and 
it may in some cases result in more difficulty hearing in everyday listening 
situations.  For example, with your cochlear implant and hearing aids off, 
hearing your own voice or detecting environmental sounds (such as the 
doorbell or the telephone ringing) may be more difficult.  A loss of low pitch 
hearing in your implanted ear may cause you to have more difficulty in 
locating the direction of a sound in the environment, or identifying a telephone 
caller as male or female. 
Speech and other sounds will not sound the same through your implant as 
they did before you lost your hearing, and may take some time to adjust to.  If 
any low pitch hearing is present after your surgery, there might be some risk 
of interference between the electrical hearing you receive from the cochlear 
implant and your low pitch hearing.  This might be all the time or sometimes.  
Any interference you might experience is expected to go away if you turn the 
cochlear implant processor off.  Even if it is difficult at first to listen with the 
cochlear implant, it may become easier over time as you gain experience 
listening with it.  If you do not benefit from the cochlear implant or do not like 

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listening with it, you can stop using the device by not using the speech 
processor.  If you decide the implant is not useful you will be provided with 
information about other options such as using hearing aids. 
There is a risk of mild irritation of the ear-canal by hearing aid earmolds or the 
ear piece of the acoustic component. 
There may be other, unknown or unforeseen side effects as part of this 
clinical trial. 
Participation is Voluntary 
Participation in any research project is voluntary.  If you do not wish to take 
part you are not obligated to.  If you decide to take part and later change your 
mind you are free to withdraw from the project at any stage.  Your decision 
whether to take part or not to take part, or to take part and then withdraw, will 
not affect your routine treatment, your relationship with those treating you, or 
your relationship with your clinic. 
Alternatives to Participating in the Research 
You may decide not to participate in this clinical study.  You may continue to 
use hearing aids.  You may elect to use transposition hearing aids, which are 
specifically designed to superimpose high-pitched information onto regions of 
lower pitch hearing that remain usable.  You may choose to receive 
specialized training to improve speech-reading and listening skills.  These 
options do not require surgery. 
Compensation for Injury 
You may develop medical complications from participating in this study.  If 
this happens, the study staff will provide emergency medical treatment and 
will assist you in obtaining appropriate medical treatment.  However, there are 
no plans to provide compensation or reimbursement for such treatments or 
for any additional costs – medical or otherwise. 
In case of injury as a result of this clinical investigation: <insert institution> will 
provide immediate medical treatment in the event that a physical injury results 
because of your participation in this research study.  You will be billed for the 
cost of such medical care not reimbursable through your health insurance. 
If you experience an injury, immediately contact the investigator: 
 
<insert Investigator Name> 
<insert Address> 
<insert Phone #> 
<insert Email> 
 

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Questions and Concerns 
Should you have questions or concerns regarding your participation in this 
research study or if you feel you have experienced a research-related injury, 
consult the investigator: 
 
<insert Investigator Name> 
<insert Address> 
<insert Phone #> 
<insert Email> 
 
Should you have questions concerning your rights as a research subject, you 
may contact: 
 
<insert Institution IRB> 
<insert Address> 
<insert Phone #> 
<insert Email> 
 
The Institutional Review Board (IRB) is a group of people who perform 
independent review of research as required by regulations. 
Authorization to Use and Disclose Information for Research 
Purposes 
Federal regulations give you certain rights related to your health information.  
These include the right to know who will be able to get the information and 
why they may be able to get it.  The investigator must get your permission to 
use or give out any health information that might identify you. 
What information may be used and given to others? 
If you choose to be in this study, the investigator will get personal information 
about you.  This may include information that might identify you.  The 
investigator may also get information about your health including: 
a) 
Past and present medical records 
b) 
Research records 
c) 
Records about phone calls made as part of this research 
d) 
Records about your study visits 
e) 
Information obtained during this research about 

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i. 
Physical exams 
ii. 
Study test results 
iii. 
Questionnaires 
iv. 
Records about the study device 
Who may use and give out information about you? 
Information about your health may be used and given to others by the 
investigator and staff.  They might see the research information during and 
after the study. 
Who might get this information? 
Your information may be given to the Sponsor of this research. “Sponsor” 
includes any persons or companies that are working for or with the Sponsor, 
or are owned by the Sponsor. 
Information about you and your health which might identify you may be given 
to:  
 The U.S. Food and Drug Administration (FDA), 
 Department of Health and Human Services (DHHS) agencies, 
 Governmental agencies in other countries, 
 <insert institution> Institutional Review Board. 
Why will this information be used and/or given to others? 
Information about you and your health that might identify you may be given to 
others to carry out the research study.  The Sponsor will analyze and 
evaluate the results of the study.  In addition, people from the Sponsor and its 
consultants will be visiting the research site.  They will follow how the study is 
being done, and they will be reviewing your information for this purpose. 
The information may be given to the FDA.  It may also be given to 
governmental agencies in other countries.  This is done so the Sponsor can 
receive marketing approval for new products or candidacy indications 
resulting from this research.  The information may also be used to meet the 
reporting requirements of governmental agencies. 
The results of this research may be published in scientific journals or 
presented at medical meetings, but your identity will not be disclosed. 
The information may be reviewed by <insert institution> IRB, a group of 
people who perform independent review of research as required by 
regulations. 
What if I decide not to give permission to use and give out my 
health information?  
By signing this consent form, you are giving permission to use and give out 
the health information listed above.  If you refuse to give permission, you will 

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not be able to be in this study. 
May I review or copy the information obtained from me or 
created about me? 
You have the right to review and copy your health information at any time.  If 
you decide to be in this study you will not be allowed to look at or copy your 
research information until the study is complete. 
May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically.  You may withdraw or 
take away your permission to use and disclose your health information at any 
time.  You do this by sending written notice to the investigator.  If you 
withdraw your permission, you will not be able to continue being in this study. 
When you withdraw your permission, no new health information which might 
identify you will be gathered after that date.  Information that has already 
been gathered may still be used and given to others.  This would be done if it 
were necessary for the research to be reliable. 
Is my health information protected after it has been given to 
others? 
If you give permission to give your identifiable health information to a person 
or business, the information may no longer be protected.  There is a risk that 
your information will be released to others without your permission. 
General Conditions 
Should you consent to participate in this research, your identity will be kept 
confidential within specific limits.  The U.S. Food and Drug Administration 
may review your records.  In addition, it may be necessary for this consent 
form and other medical records to be reviewed by representatives of other 
appropriate regulatory agencies and Cochlear Americas. 
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not 
include information that can identify you.  At most, the Web site will include a 
summary of the results.  You can search this Web site at any time. 
All forms of medical diagnosis and treatment, whether routine or 
experimental, involve some risk of injury.  Despite all precautions, you may 
develop medical complications from participating in this study.  Should such 
complications arise, the researchers will provide emergency medical 
treatment and will assist you in obtaining appropriate medical treatment.  
However, this study does not provide compensation or reimbursements for 
such treatments or for any additional costs – medical or otherwise. 
Your Participation in this Research is Voluntary 
You may withdraw from the research project at any stage.  Should you decide 
to participate in this study, and later elect to discontinue, you may withdraw 

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without penalty or loss of benefits to which you are otherwise entitled.  You 
may withdraw from the study by notifying your audiologist or surgeon.  
Additional Information 
a. 
The study may be stopped earlier than anticipated. 
b. 
Any important new findings made during the course of the research will 
be provided to you.  This may affect your willingness to continue in the 
study. 
c. 
Your participation in this study does not limit any protection or rights 
you may have pursuant to any applicable federal, state or local laws. 
d. 
Your participation may be ended by the investigator without your 
consent IF: 
 Such participation is shown to be life threatening or hazardous. 
 There are unanticipated business, legal or regulatory 
circumstances that make continuation impossible or 
commercially impractical. 
 
 

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Release of Information: 
I give permission for Cochlear Americas to have access and copying rights to 
all medical and hospital records concerning my participation in this research.  
I also authorize Cochlear Americas, the U.S. Food and Drug Administration, 
and other regulatory authorities to use this information.  I, otherwise, do not 
allow disclosure of any information that is individual or personal to me. 
 
Name of Participant: 
 
 
 
 
 
 
Signature: 
 
 
 
 
 
 
 
Date:  
 
 
 

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Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear 
Implant in Adults 
INFORMED CONSENT 
Do not sign this consent form unless you have had a chance to ask questions 
and have received satisfactory answers to all of your questions. 
If you agree to be in this study, you will receive a signed and dated copy of 
this consent form for your records. 
Agreement to Participate: 
I have read and understand the description of the “Safety and Efficacy of the 
Cochlear Nucleus CI422 Cochlear Implant in Adults” study.  I hereby consent 
to the research as described. 
I understand the risks, benefits and alternatives to participation in this clinical 
trial. 
I certify that: 
 
 I  am  / am not  (circle one) participating in another research project at 
this time. 
 I have discussed the implications of such activity, if any, with the 
Primary Investigator of this project. 
 
In consideration of this understanding, I voluntarily agree to enroll in this 
research at: 
 
<insert institution> 
 
 
 
Print Participant Name 
 
 
 
Participant Signature 
Date 
Print Person Name of 
Person Obtaining Consent 
Signature 
Date 

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Appendix A 
Warnings and Precautions for the Nucleus Cochlear Implant 
a) Long-term Effects of Electrical Stimulation - - Most cochlear implant 
recipients benefit from electrical stimulation at levels that are 
considered safe, based on animal experimental data.  For some 
recipients, the levels needed to produce the loudest sounds exceed 
these levels.  The long-term effects of such stimulation in humans are 
unknown.  
b) Head Trauma - - A blow to the head in the area of the cochlear implant 
may damage the implant and result in its failure. 
c) Ingestion of Small Parts - - The external cochlear implant system 
contains small parts that may be hazardous if swallowed. 
d) Batteries can be harmful if swallowed.  Ensure that batteries are kept 
out of reach of young children.  If swallowed, seek prompt medical 
attention at the nearest emergency center. 
e) Scuba Diving- - Recipients of a cochlear implant should seek medical 
advice before participating in a dive for conditions that might make 
diving contraindicated, e.g., middle-ear infection, etc.  When wearing a 
mask, avoid pressure over the implant site.  Maximum diving depth for 
the Nucleus cochlear implant is 40 m or 131 feet. 
f) Rechargeable Batteries - - In certain circumstances, rechargeable 
batteries can become VERY HOT, and could cause injury.  
Rechargeable batteries should NEVER be worn beneath clothing 
(including scarves and headwear covering the ears).  Use of the 
rechargeable battery is contraindicated in patients who cannot remove 
the device by themselves, or notify a caregiver that the device has 
become hot. 
g) Sleeping - - Do not wear the sound processor while sleeping, as you 
may not become aware of your processor becoming unusually warm or 
hot. 
h) Retention aids - - When using retention aids such as the Snugfit™ or 
LiteWear, be aware that it may take longer to remove the processor if 
the processor becomes unusually warm or hot.  Do not attach the 
LiteWear beneath layers of clothing. 
i) Electromagnetic Interference - - Some types of digital mobile 
telephones or hand-held communication devices (e.g., walkie-talkies) 
may interfere with your cochlear implant system.  You may perceive 
distorted sound when you are within 12 feet of such devices.  You may 
experience distorted sound when passing through or near devices 
such as airport metal detectors and commercial theft detection 
systems.  You may need to turn off your sound processor when near 
such systems.  The system may activate metal detectors.  You should 

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carry the Cochlear Implant Patient Identification Card with you at all 
times.  Sound quality may also be distorted when you are within one 
mile of a radio or television transmission tower.  The effect is 
temporary and will not damage your system. 
Warnings Regarding Specific Medical Treatment: 
Some medical treatments generate induced currents that may cause tissue 
damage or permanent damage to the cochlear implant. 
a) Electrosurgical instruments (electric instruments used to cut tissue or 
bone or stop bleeding) are capable of producing radio frequency 
currents that may flow through the electrode array.  Monopolar 
electrosurgical instruments must not be used on the head or neck of a 
cochlear implant recipient, as induced currents could cause damage to 
cochlear tissues or permanent damage to the implant.  Bipolar 
electrosurgical instruments may be used on the head and neck; 
however, the cautery electrodes must not contact the implant and 
should be kept more than 1 cm (about 1/2 inch) from the extracochlear 
electrodes.  
b) Therapeutic or medical diathermy (treatment that involves heating 
body tissue) using electromagnetic radiation (magnetic induction coils 
or microwave) must not be used.  High electric currents, which may be 
induced into the electrode array from these procedures, can cause 
tissue damage to the cochlea or permanent damage to the implant.  
c) Neurostimulation (stimulating the brain or parts of the brain with 
electricity) must never be applied directly over the cochlear implant.  
High currents induced into the electrode array can cause tissue 
damage to the cochlea or permanent damage to the cochlear implant.  
d) A cochlear implant recipient must not undergo electroconvulsive 
therapy (shock therapy) under any circumstances.  Electroconvulsive 
therapy may cause tissue damage to the cochlea or damage to the 
cochlear implant.  
e) Recipients of cochlear implants should not undergo ionizing radiation 
therapy directly over the cochlear implant.  
f) Magnetic Resonance Imaging (MRI) is contraindicated except under 
the circumstances described below.  Cochlear implant recipients must 
not be in the room where an MRI scanner is located, except under the 
following special circumstances: 
 Nucleus cochlear implant system has a removable magnet and 
specific design characteristics to enable it to withstand MRI up to 
1.5 Tesla, but not higher.  The cochlear implant magnet must be 
surgically removed prior to an MRI procedure.  
 Cochlear implant recipients must take off the sound processor and 
headset before entering a room where an MRI scanner is located.  

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 If the implant’s magnet is still in place, tissue damage may occur if 
the recipient is exposed to MRI.  Once the magnet is surgically 
removed, the metal in the cochlear implant will affect the quality of 
the MRI.  Image shadowing may extend as far as 6 cm from the 
implant, thereby resulting in loss of diagnostic information in the 
vicinity of the implant.  
 If you need additional information about removal of the magnet, 
please contact Cochlear Americas.