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This web page has been created for patients who are
interested in becoming participants in the Envoy Esteem™ Clinical Research Trial.
**Please note: the current clinical research study, protocol 0204, was closed for accrual on July 9, 2008. Please print out the following documents (available in either .pdf or MS Word format): 1. Medical History Questionnaire - please complete the
questionnaire and return to us by email, regular mail, A.
Medical History Questionnaire in .pdf file format or 2. Esteem Appointments Summary - a summary for your reference A.
Appointments Summary in .pdf format or 3. SCA Surgical Center of Greensboro Patient History Form & Medication Form A.
SCA Surgical Center Patient History Form & Medication Form in .pdf format - please print out
both Please read the following documents or page: 1. Screening & Baseline Subject Informed Consent Form in pdf file format 2. Surgical Subject Informed Consent Form in pdf file format 3. Map & Directions to our office in Greensboro, NC 4.
SCA Surgical Center Outpatient Information Brochure in .pdf format -
includes a
The Esteem™ Totally Implantable Middle Ear Device (TIMED) is an investigational device. It has not been approved by the United States Food & Drug Administration. This is the reason that the Esteem™ Clinical Trial is being conducted. The Esteem™ System was approved in Europe, July 2006, and was granted a CE mark. Esteem™ implants are being performed in Europe on a regular basis. The Esteem™ Clinical Research
Trial for 2008 has been approved by the US Food & Drug
Welcome to our Envoy Clinical Trial page! You will find important information concerning the 2008 Envoy Esteem™ Clinical Trial as well as information concerning our Esteem™ Implant team. The Envoy Esteem™ Clinical Trial protocol and informed consents were approved by the Moses Cone Health System Institutional Review Board on October 9, 2007. If you would like to become a voluntary
participant in the Envoy Esteem™ Clinical Trial, please read the information
carefully. Participants are required to meet all inclusion criteria.
If you do not find answers to your questions here, please fell free to contact
our audiologists, Amy Daughton, at email address
amdaughton@earcentergreensboro.com or Stephanie Nance at
snance@earcentergreensboro.com.
Definition: A Clinical Trial is a type of clinical research study. Participants are enrolled in clinical trials in order to study new medical treatments, medications, or devices. The Esteem™ device is an investigational totally implantable device that is being studied to determine its safety and efficacy for the treatment of mild to severe sensorineural hearing loss. Voluntary Participation: If you are considering enrolling as a participant in the Envoy Esteem™ Clinical Trial, it is important that you understand the nature of the research and understand the general principles that apply to all who take part in a research study. Taking part in the study is entirely voluntary. Personal benefit may or may not result from taking part in the study, but knowledge may be gained that will benefit others. You may refuse to take part or withdraw from the study at any time. Informed Consent: If you decide to take part in the research study, you will be asked to sign a Screening & Baseline Subject Informed Consent Form and a Surgical Subject Informed Consent Form acknowledging your understanding of the research being performed and giving your permission to participate. The nature of the study, as well as the risks and other important information about the study are described in detail in the informed consent documents.
Questions: Take time to ask the study doctor or study staff as many
questions about the study as you would like. If there are any words or
information that you do not understand, the study doctor or study staff will
explain them to you. Reading the information contained on this web site
and talking to the study doctor and study staff may help you to decide whether
to take part or not.
Sponsor: The study is being
sponsored by Envoy Medical Corporation, St. Paul, MN. For more information
concerning the Sponsor, you may visit their
web site at
www.envoymedical.com. Which Investigational Sites are Participating in the Clinical Trial? Investigational Sites: Currently, there are three investigational sites that will be participating in the Esteem™ Clinical Trial. In addition to our team at the Ear Center of Greensboro, P.A., Greensboro, NC (Eric M. Kraus, M.D., M.S.), investigational teams are located at Shohet Ear Associates, Newport Beach, CA (Jack Shohet, M.D.) and at the Lahey Clinic, Burlington, MA (Peter Catalano, M.D.)
How Do I Become a Participant in the Envoy Esteem™ Research Study? In order to become a participant in the research study, you will need to: 1. Be able to meet all of the study's
inclusion criteria - 2. Complete the
Medical History
Questionnaire - **Click
here for a copy of the Medical History Questionnaire in MS Word format. A. Screening & Baseline Subject Informed Consent document - click here to download in pdf format B. Surgical Subject Informed Consent document - click here to download in pdf format
3. Contact us or the study Sponsor: A. Our
Greensboro Team:
www.earcentergreensboro.com, (336) 273-99332 4. Travel to Greensboro, NC for
screening informed consent, watching an informational DVD, 6. Be provided with, and sign, the formal informed consent document 7. Undergo and pass necessary
diagnostic tests (a CT scan of your ears for surgical considerations 8. Undergo preoperative hearing testing with and without hearing aid(s) 9. Be willing to comply with all of the
requirements of the study and
What is the Envoy Esteem™ Totally Implantable Hearing Device? The Esteem™ Totally Implantable Hearing Device (TIMED) is a totally implantable hearing system that is implanted under the skin behind the ear and in the middle ear space. The Esteem™'s purpose is to help improve hearing in adult patients who have mild to severe sensorineural hearing loss, and who have at least 60% or better discrimination of words (WRS). The goal is to provide comfortable, natural sounding, high fidelity sound to participants with sensorineural hearing loss by direct driving of inner ear fluid.
Figure 1 Esteem™ Device Graphic: An Envoy
Esteem™ Totally Implantable Middle Ear Device (TIMED) is shown
Components: The totally implanted Esteem™ Device is composed of two piezoelectric bimorph crystals connected to a Sound Processor (contains electronics and battery source). One piezoelectric crystal, the Sensor, is interfaced to the second hearing bone (the incus). The Sensor serves, in conjunction with the patient’s native eardrum (tympanic membrane), as a “semi-biologic” microphone. The eardrum serves as the "diaphragm" of the microphone. The second piezoelectric crystal, the Driver, is coupled, through a facial recess tympanomastoidectomy surgical approach (a standard ear surgery procedure), to the third hearing bone (the stapes). During the surgical procedure, the incus is separated from the stapes to prevent feedback vibrations. Sound Pathway: Sound signals enter the ear canal and vibrate the eardrum and incus. The vibrations are then “sensed” from the incus by the Sensor . The sound signal is then “relayed” to the implanted Sound Processor to be amplified and processed. The processed signal is “relayed” to the Driver that is coupled to the third hearing bone, the stapes. The stapes vibrates fluid within the inner ear (the cochlea). The fluid vibrations cause tiny hair cells within the cochlear to send neural signals to the brain that result in the sense of hearing. No External Hardware to Wear: Because the Esteem™ is totally implantable, the participant does not wear any external hardware. The Esteem™ is totally invisible. Nothing is worn in the ear canal or behind the ear. Bathing and swimming are possible without removing any external components. Participants may leave their Esteem™ device turned on 24/7 just like their natural ear. No More Hearing Aid Hassles: No more fumbling around in the dark at night to find your hearing aid. No more embarrassing situations when your hearing aid batteries suddenly die. No more ear canal infections from hearing aid molds. No more occlusion effect from a hearing aid blocking your ear canal. No more broken battery doors, cracked tubing, and ear wax blocking the microphone. No more lost hearing aids when you jump into the water without removing your aids or inadvertently send the hearing aid to the dry cleaners in your shirt pocket. No more hearing aid batteries...period. iPod-like Personal Programmer: A small remote control device that looks like an iPod, the Personal Programmer", is used by the patient to control the Esteem™ for volume, distance, etc. The Personal Programmer uses standard batteries and has USB capability. Computer Programmability: In addition to the participant's ability to control their Esteem™, the implanted Sound Processor is totally computer programmable by our audiologists using special Commander Software. Battery Power: Energy for the implanted Esteem™ Sound Processor is provided by a non-rechargeable battery that is hermetically sealed within the Sound Processor. Participants never have to change batteries or charge batteries. Battery life of the Esteem™ sound processor is approximately 4.5 - 8 years depending on individual power requirements. Two months before the internal battery becomes depleted, the participant will hear a tone to signal that a sound processor/battery change is necessary. MRI Incompatibility: After being implanted with an Esteem™ device, participants may not undergo magnetic resonance imaging (MRI scanning involving exposure to strong magnetic fields). CT scanning (involving conventional x-ray irradiation) is permitted.
How Many People Have Had an Esteem™ Device Implanted in the United States?
United
States:
The first part of the Esteem™ Clinical Trial was performed from
2004-2006. A total of seventy-two (72) participants were implanted.
The first part of the Esteem™ Clinical Trial was closed to Greensboro, NC: Of the 72 implants in the USA, 20 patients were implanted in Greensboro.
What is the surgical procedure that is used to implant the Esteem™ Device?
Surgical Procedure:
The Esteem™ device is implanted behind the ear and in the
middle ear space during a 3-4 hours surgical procedure. The operation is
performed under general anesthesia at an ambulatory surgery center, the
SCA Surgical Center of Greensboro, Greensboro,
NC. The Surgical Center is located five blocks from our office.
Click here to download a copy of the SCA Surgical Center of Greensboro
Outpatient Information
Click here to download copies of the SCA Surgical Center of Greensboro Patient
History Form
What happens when the Sound Processor Battery Becomes Depleted? Sound Processor Exchange: Sound processors are explanted and new processors are implanted during a one hour surgical procedure that is performed in an ambulatory surgery center using local anesthesia and light sedation. Sound processor exchanges are similar to exchanging a cardiac pacemaker. When an exchange is performed, the participant automatically receives an updated, state-of-the-art Sound Processor along with a fully charged battery, as permitted by regulation.
If you would like to learn more about the
investigational Esteem™Clinical Trial, please contact To learn more about our implant team and our office, please visit the rest of our web site. You may also visit the Envoy Medical Corporation's website at: www.envoymedical.com
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DISCLAIMER: Please note that this web site is not designed to, and does not, provide medical advice. All of our content, including text, graphics, images, photographs, charts, maps, information, etc. that has been made available on or through this web site, is provided for general information purposes only. The content is not intended to be a substitute for obtaining professional medical advice, diagnosis, or treatment. Do not delay in seeking medical advice and do not disregard professional medical advice once obtained because of information that you have obtained on this web site. It is a good idea to never rely on information from this web site, or any web site, in place of seeking up-to-date, professional medical advice. For additional information, please see our main Disclaimer Page.
Copyright © 2009 by The Ear Center of Greensboro, P.A. All rights
reserved.
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