Envoy Participant Appointments Summary - Post Approval Study (PAS)

Click here for a PDF of the Appointment Summary Flow Sheet

Day #1

INITIAL VISIT
Purpose: to determine candidacy for the Post Approval Study. Screening & Baseline Subject Informed Consent will be signed. Watch an informational Esteem DVD, and have an Otogram hearing testing.

Day #2

MEDICAL HISTORY & PHYSICAL EXAM BY DR. KRAUS
Purpose: to have a medical history and physical examination by one of our surgeons. You will have a medical history and physical examination. A surgeon will provide you with informed consent. After all of your questions have been answered, you will be asked to initial and sign the Formal Informed Consent document.

PAS QUESTIONNAIRE

Purpose: to complete the questionnaire required by the Post-Approval Study.

CT SCAN OF HEAD & EARS

Purpose: to determine status of ear anatomy and permit mastoid measurements for transducer fit. Performed at Southeastern Radiology if one has not already been completed.

PREGNANCY TEST (for women of child bearing age and otherwise, if indicated)

Purpose: to determine if participant is pregnant. Women of child bearing age who have not had a hysterectomy or tubal ligation are required to have a negative pregnancy test in order to participate in the PAS study.

QUESTIONNAIRES

Purpose: to gather participant specific information concerning hearing ability, etc.

BASELINE HEARING TESTING WITH & WITHOUT HEARING AIDS

Purpose: to measure preoperative hearing ability with and without hearing aids. A full audiometric evaluation will be performed as per the PAS requirements.  Days to be determined

PREOP EXAM

Purpose: to re-examine your ears and general medical condition prior to surgery. Review surgery and answer questions.

SURGERY

The surgery will be conducted at the SCA Surgical Center of Greensboro, 1211 Virginia Street, Greensboro, NC. The procedure may take 4-5 hours and is performed under general anesthesia. You will stay overnight.

POST OP APPOINTMENTS
You will be required to return for 2-6 follow up appointments, depending on recovery. Your first appointment will be at 7-10 days post-operation to remove skin sutures/staples and to assess healing progress.

DEVICE ON - 8 weeks postoperative

8 weeks after the surgery, you will return to have your Esteem turned-on. You will leave the office with your device turned on. This is a great time to bring your spouse, friend, or family member. Estimated time for the appointment is 1-11/2 hrs. The device will not be finely adjusted to permit you to adjust to your new hearing ability.

FORMAL DEVICE ACTIVATION & ADJUSTMENTS

Two weeks following your Device-on visit, you will return for computer adjustment and fine tuning of your Esteem device. More intensive hearing tests will be performed. Estimated time for the appointment is 3-4 hrs.

ONE MONTH

One month after Device-on, you will return for 3-4 hrs of reprogramming and testing.

TWO MONTHS

Two months after Device-On, you will return for 3-4 hrs of reprogramming and testing.

FOUR MONTHS

Four months after Device-On, you will return for 3-4 hrs of reprogramming and testing.

TEN MONTHS

Ten months after Device-On, you will return for 3-4 hrs of reprogramming and testing.

1 YEAR

1 year after Device-On, you will return for 3-4 hrs of reprogramming and testing.

2 YEARS

2 years months after Device-On, you will return for 3-4 hrs of reprogramming and testing.

3 YEARS

3 years after Device-On, you will return for 3-4 hrs of reprogramming and testing.

4 YEARS

4 years after Device-On, you will return for 3-4 hrs of reprogramming and testing.

5 YEARS

5 years after Device-on, you will return for 3-4 hrs of reprogramming and testing.

Please email Amy Daughton at amdaughton@earcentergreensboro.com or Stephanie Nance at snance@earcentergreensboro.com or call our Audiology Department at (336) 273-9932 if you have any questions.