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Enrollment

Implanted at 7 months to 5 years, 11 months of age

Implanted between January 1, 20xx and April 30, 2021

Electronic health record includes at least one safety data point below

  • Total duration under anesthesia
  • Estimated blood loss
  • Total duration in recovery
  • Readmissions to CI center/hospital within 30 days post-surgery
  • Amount of pain medication administered in hospital
  • Temperature regulation issues and/or any instances of arrhythmia
  • Facial nerve injury
  • Exposed dura during drilling
  • Skin flap breakdown or extrusion
  • Device malfunctions
  • Any other device- or procedure-related complication noted in the electronic health record
Implanted at ≥12 months of age with a bilateral, profound SNHL

Lost-to-follow-up before 10 months post-activation

Pre-operative Data

A. History (NA indicates that information is not available in the subject’s health records.)


Sex

Age at identification

Age at first HA fitting

Age of hearing loss

Was the child receiving aural habilitation before surgery?

Mode of communication

B. Medical History (NA indicates that information is not available in the subject’s health records.)

Answer the following questions from patient records BEFORE IMPLANTATION. If the answer to any question “Yes,” open comment box with unlimited characters.


Was the patient born prematurely (less than 37 weeks)?

Was the patient diagnosed with any congenital abnormalities/syndromes?

Was the patient diagnosed with any comorbidities?

Was the patient diagnosed with any airway issues/respiratory conditions?

Was the patient diagnosed with failure to thrive?

Was the patient diagnosed with meningitis?

Did pre-operative imaging indicate an abnormal course of the facial nerve?

Did pre-operative imaging indicate any facial abnormalities?

Did pre-operative imaging indicate any cochlear abnormalities?

Did pre-operative testing indicate any retrocochlear abnormalities?

C. Audiometric Testing (NA indicates that information is not available in the subject’s health records.)


Was objective testing conducted before surgery (e.g., ABR, OAE, ASSR)?

Were unaided thresholds tested behaviorally before surgery?