Cochlear implant performance and safety study

Who can take part

• You have received a MED-EL cochlear implant.
• Your implant surgery was done at Inselspital Bern.
• Your implant surgery was in 1996 or later.
• You are not taking part in this study; your existing medical records will be reviewed.
• Your implant was a standard device, not custom-made or part of an early research study.
• You have not withdrawn consent for your data to be used.
• You were under 18 when you got your MED-EL cochlear implant.
• You did not have a previous cochlear implant on the same side before this one.
• You had a test for COVID-19.
• The date you became aware of your hearing loss.
• You had an infection at the surgical site within 30 days of the surgery.
• Your surgery was a replacement or revision surgery.
• You have a condition that caused your hearing loss to be progressive.
• You have been pregnant since your cochlear implant surgery.
• You have had meningitis.
• You have had a follow-up appointment at Inselspital Bern.
• You will not have a follow-up visit in the future.
• You have not had a medical imaging test of the head since the implant.
• You had a brain scan since your implant.
• You have any other type of hearing implant.
• Your hearing loss developed before you learned to speak.
• You have had a CT or MRI scan.
• You have had complications after the implant.
• You are allergic to the materials in the device.
• You had a previous implant surgery on the same ear.
• You are current with your vaccinations.
• You are 18 years old or older now.
• You oral consent to participate in this study.
• You have the ability to understand the request to participate in this study.
• You have read and understood the information sheet.
• You understand that your participation is voluntary.
• You are willing to participate in the study.
• You feel you have the capacity to decide about your participation.
• You are comfortable communicating in German.
• You are currently a patient at Inselspital Bern.
• You withdrew your consent for the study.
• You object to the use of your data for this study.
• Your data can be linked to you.
• You had the implant removed.
• You are participating in another study.
• You are unable to give informed consent.
• You have no other serious medical conditions.
• You have been discharged from the hospital.
• You have had the implant for at least one year.
• You were 18 or older at the time of the implant.
• You were 18 or older on 1st January 1996.
• You have not had a meningioma.
• You have not had a cholesteatoma.
• You have not had a fracture in the ear bone.
• You have not had a condition that blocks the inner ear.
• You have not had a genetic or hereditary cause of hearing loss.
• You have not had a viral or bacterial infection of the inner ear.
• You have not had an autoimmune disease of the inner ear.
• You have not had a tumor of the ear or hearing nerve.
• You have not had a stroke.
• You have not had a traumatic brain injury.
• You have not had a condition that affects the nerve that carries sound to the brain.
• You have used Sign Language as your primary communication method.
• You have not had a previous implant.
• You are not allergic to any medications.
• You are not pregnant.
• You have not had a lumbar puncture.
• You are not a prisoner.
• You are not a member of a marginalized group.
• You are not an employee of the sponsor or hospital.
• You have good hearing in the other ear.
• You have a good result with the implant.
• You have a severe hearing loss.
• You have a profound hearing loss.
• You have a T-cell deficiency.
• You have a B-cell deficiency.
• You are not on a path to receive a hearing organ transplant.
• You have not had a heart attack in the last 3 months.
• You have not been diagnosed with a life-threatening disease.
• You have not had a bone marrow transplant.
• You have not participated in another clinical trial in the last 30 days.
• You have not participated in this trial before.
• You have no conflicts of interest.
• You have not been institutionalized.
• You are not under legal guardianship.
• You are 18 years or older.
• You are not currently receiving emergency care.
• You are not admitted to hospital with a condition that impairs your ability to give consent.
• You have not received an experimental drug or device.
• You have not had a history of non-adherence to medical therapy.
• You are not a ward of the state.
• You are not a member of a group that is often vulnerable to coercion or undue influence.
• You have not been diagnosed with a mental impairment that prevents you from understanding the study.
• You are not a primary care physician's direct supervisor.
• You are not a student of the principal investigator.
• You are not a member of the investigator's household.
• You have not been selected because you are committed to an institution.
• You have not been admitted to an institution under a legal or administrative order.
• You have not been deprived of your liberty
• You are not under the influence of alcohol.
• You have not tested positive for COVID-19 in the last 10 days.
• You have not been in contact with a positive case of COVID-19 in the last 14 days.
• You do not have a fever.
• You do not have a cough.
• You do not have loss of taste or smell.
• You have not traveled abroad in the last 14 days.
• You are not in the care of the hospital.
• You do not have a cochlear implant.
• You have not had a cochlear implant.
• You do not want a cochlear implant.
• You have a MED-EL implant.