SCREENING & BASELINE SUBJECT INFORMED CONSENTearcentergreensboro.com/forms/documents/envoy/... · APPROVED MAR 1 0 2009 Moses Cone Health System Institutional R9view Board SCREENING

APPROVEDMAR 1 a 2009

Moses Cone Health SystemInstitutional Review Board

SCREENING & BASELINESUBJECT INFORMED CONSENT FORM

Envoy Medical Esteem@ Totally Implantable Hearing System Clinical Trial 0204

Title: Envoy Medical Esteem® Totally Implantable Hearing System Clinical Trial 0204

IRB Project Number: 10/07-1179

PrincipallnvestiQator: Eric M. Kraus, M.D., M.S., FAC.S.

The Ear Center of Greensboro, PA

Greensboro, NC 27401

Phone: (336) 273-9932

Sponsor: Envoy Medical Corporation, St. Paul, MN

THE OPPORTUNITY

You are being offered an opportunity to be Screened and to have Baseline Audiological Testingpreformed to determine your eligibility to participate in a clinical study involving a new totally implantablehearing device, the Esteem. You are being asked for your permission to be screened so that a generalassessment of your eligibility can be determined before having to go through a more extensivescreening process.

The information collected and evaluated in the screening process is used to determine your eligibility toparticipate in a clinical research study. If you qualify based on your medical records and baseline testresults, a member of the study team may contact you to further discuss the study with you and to offeryou the chance to take part in the study. You will then have the opportunity to ask additional questionsand to either agree to participate in the trial or to decline participation.

If this consent contains words or information that you do not understand, please ask your doctor oraudiologist to explain them to you. We want to make sure that you fully understand the screeningprocess and baseline testing and the part that it will play in your eligibility to participate in the study. Youmay take an unsigned copy of this consent form home with you to think about or discuss with familymembers or friends before making your decision. If you decide to participate in the screening process,you will receive a copy of this form to keep.

It is important that you have previously wom a hearing aid and that your hearing aid has beenappropriately fit.. Your hearing will be tested with and without your hearing aid as part of the baselinetesting. This information will be used to compare your hearing with your current hearing aid and yourhearing with the Esteem.

CONFIDENTIAL

Envoy Medical CorporationProtocol # 0204 Revision 02

Envoy Medical document #003900-101 Protocol Date: 29 October 2007Patient Initials: _

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DESCRIPTION OF TESTS

During the screening part of this study, your doctor/audiologist will review your medical records to ensurethat there is nothing in your medical history that would prohibit you from participating in the clinical study.He or she may then perform a number of audiological tests to assess your hearing loss with and withoutyour hearing aid(s). These tests are similar to hearing tests that you have had before and are listedbelow. You may also be asked to fill out some questionnaires about your hearing loss and your life.

• Quality of Life (QOL) Questionnaires

• Otoscopic Exam (examination of your ears with lighted instruments)

• Tympanogram (a test that measures the movement of your eardrums)

• Air Conduction Thresholds

• Bone Conduction Thresholds

• Most Comfortable Listening Level (MCL)

• Uncomfortable Listening Level (UCL)

• Speech Reception Threshold (SRT)

• Word Recognition

• Quick SIN (a speech-in-noise test)

You may also be asked to have a CT scan of your ears (computerized x-ray test) to further evaluate youreligibility for enrollment into the study. If you have had a standard of care CT scan within 6 months ofstudy screening procedures, this data may be acceptable for use in fulfilling the related inclusion criterion.

Once all of the hearing tests have been completed, if you have met all of the medical criteria for the study,you may be invited to participate in the clinical study. There is the possibility that you may not be eligiblefor the clinical study.

There are no potential risks or discomforts associated with the screening and baseline testing. Theaudiological tests are standard hearing tests which may already be familiar to you.

COSTS AND COMPENSATION

You will not be paid to participate in this screening process. There will be no charge for the hearing testsperformed. Envoy Medical Corporation will pay for all Screening and Baseline testing.

If you complete all screening and baseline testing and are invited to participate in the clinical study, youare not obligated for any costs associated with the tests if you decide to decline the invitation.

CONFIDENTIAL



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APPRC)VEDi1AR 10 2009

Moses Cone Health SystemInstitutional Rtview Board


Envoy Medical Esteem® Totally Implantable Hearing System Clinical Trial 0204

CONFIDENTIALITY

Your privacy is important. All information gathered in this study will be kept private. If the results of thestudy are published, information will not be included that would make it possible to identify you. Noinformation will be disclosed about you except that which may be required by law.

Your doctor, authorized personnel of your doctor, Envoy Medical Corporation (the study sponsor), itsemployees or agents, the Institutional Review Board of the Moses Cone Health System, and the U.S.Food and Drug Administration, have the right to review and to copy: (1) your medical records (which mayidentify you), (2) the consent form signed by you, and (3) the information collected in this study to makesure that the information is true and accurate. It may be necessary to review your medical records forany medical conditions or treatment that you have received prior to signing this consent form. Theinformation may be given to governmental agencies in other countries where the Esteem System may beconsidered for approval. Envoy Medical and your doctor will keep the data collected from this study forapproximately ten (10) years.

RESEARCH STUDY AUTHORIZATION OF PROTECTED HEALTH INFORMATION

In order to determine your eligibility for this study, you must allow certain research (study) records aboutyou to be made and used in the screening and baseline process. These records are in addition to theusual records the hospital and your doctor create about your medical treatment. The data that iscollected from these records will be shared with other people involved in the study such as the studysponsor and its representatives, other study sites, other doctors, and other hospital institutional reviewboards (IRB). If this data is shared with other people, you will be identified by an 1.0. code wheneverpossible. By signing this consent form, you are authorizing your doctor to create and use these records.

There is no expiration for this authorization unless you cancel it in writing. You may cancel thisauthorization by writing to your doctor a the following address: Eric M. Kraus, M.D., M.S., F.A.C.S., TheEar Center of Greensboro, PA, 1126 N. Church Street, Suite 201, Greensboro, NC 27401. If you cancelyour authorization, you may not be invited to participate in the study. Canceling your authorization onlyaffects the use and sharing of new information. Any information collected before you cancel can still beused and shared. By signing this consent document, you are giving your permission to use and shareyour Screening and Baseline information and medical records.

VOLUNTARY NATURE OF SCREENING AND BASELINE TESTING

You do not have to be screened for this study if you do not want to. Your decision whether or not to takepart will not change your current or future relationship with your doctor or hospital. If you decide not totake part, you will not lose any benefits or be penalized in any way. If you decide to take part, you arefree to quit at any time. Your doctor has the right to end your participation in this process even withoutyour consent if he feels that you are not a good candidate or have not fulfilled the requirements of theclinical study.

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SUMMARY OF PRELIMINARY SAFETY AND EFFECTIVENESS DATA

Fifty (50) subjects have completed the 4 month follow-up per the clinical protocol. The preliminary .safety and effectiveness data for the primary and secondary objectives indicates that the Esteem isthought to be safe and effective for treating sensorineural hearing loss. Preliminary results at the 4month endpoint are provided below:

• Primary Objectives:1) Speech Reception Threshold (SRT): SRT scores with the Esteem have improved by 11

± 2 dB (Confidence Interval- 7,14) over the aided baseline condition.2) Word Recognition Score (WRS): WRS at 50 dB are better than the aided baseline

condition (Hearing Aid) in 58 % of subjects, equal to Hearing Aid in 30 %, and belowHearing Aid in 12 % of subjects.

3) Serious Adverse Device Events (SAD E) and device failure/revisions: 3 SADE (5.3 %)and 2 failures (3.5 %) requiring revision to correct have occurred in the 57 subjectsimplanted with Esteem.

4) Cochlear function stability (Bone Conduction Safety Algorithm): All subjects passed thebone conduction safety algorithm per the clinical protocol demonstrating that the subject'scochlear function remains unchanged with the Esteem system .

• Secondary Objectives:1) Pure Tone Average (PTA): The 3-frequency PTA is better than the unaided baseline

condition in 96 % of subjects, the same in 4 % and less than in 0 %. PTA improves 27 ±1 dB (Confidence Interval - 24, 30) over the unaided baseline condition.

2) QuickSIN: Esteem shows equivalent improvement in the subject's ability to understandspeech in noise as the aided baseline condition as indicated by a change in QuickSINscore of -1 ± 1 (Confidence Interval -2, 0).

3) Abbreviated Profile of Hearing Aid Benefit (APHAB): Total APHAB score is better thanthe aided baseline condition (Hearing Aid) in 60 % of subjects, equal to Hearing Aid in 20%, and below Hearing Aid in 20 % of subjects. Similar results are shown for the subcategories of APHAB.

4) Esteem Questionnaire: The Envoy Questionnaire shows that a large number of thesubjects consider the Esteem somewhat or much better than their baseline hearing aid.o 78% rated the Clarity of Sound as somewhat or much better• 68% rated the Ability to Understand Speech in background noise as somewhat or

much better

o 75% reported Voices Sounding Natural as somewhat or much better• 72% reported Understanding Conversation when several people are talking as

somewhat or much better

• 86% said their Activity level was somewhat or much better

If you have any questions, your doctor can provide an explanation of these test results.

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MOaesCone Health System!mititutt¢MI Review Board



WHOM TO CONTACT WITH QUESTIONS

If you have any additional questions concerning the Esteem System, please contact your doctor, Dr. EricM. Kraus at (336) 273-9932. If you have any questions regarding your rights as a research participant,you may contact the chairman of the hospital Institutional Review Board (IRB) listed below.

IRS Contact: Charles Wilson, M.D., Chairman, Moses Cone Health System IRB

Phone Number: (336) 832-8745

SIGNATURE SECTION

Please read and sign the following to give your consent to take part in thisclinical study: I understand that my participation in this Screening - Baseline Testing is by freechoice and that I may withdraw my consent at any time without punishment, discrimination or loss ofbenefits to which I am entitled. I have read the above information contained in this Screening - BaselineSubject Informed Consent Form (or it has been read to me). When I did not understand something, Iasked questions and received a satisfactory answer.

I authorize the release of my medical records for research or regulatory purposes to study sponsor,Envoy Medical Corporation, the Food and Drug Administration, other appropriate governmental agencies,and the Moses Cone IRB. I agree to allow the research personnel specified above to make copies of saidmedical records and Screening - Baseline Testing data collected during this screening process and/orstudy as needed. I now fully understand all of the information and consent to the Screening - BaselineTesting which may determine my eligibility to participate in the clinical study.

A signed copy of this consent form will be given to me.By signing this consent form, I understand that I have not waived any of my legal rights to which Iotherwise would have as a subject in a research study.

Subject Signature

Subject Name (Printed)


Envoy Medical document #003900-101

Date

CONFIDENTIAL

Protocol Date: 29 October 2007

Time

Patient Initials: _Page 5 of 6

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Signature of Person Conducting Infonned Consent Discussion Date

Person Conducting Infonned Consent Discussion (Printed)

Name of Hospital/Institution

Principal Investigator's Signature

Principal Investigator's Signature

Principal Investigator's Name (Printed)

CONFIDENTIAL

Date

Time

Time



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SCREENING & BASELINE SUBJECT INFORMED CONSENTearcentergreensboro.com/forms/documents/envoy/... · APPROVED MAR 1 0 2009 Moses Cone Health System Institutional R9view Board SCREENING