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A Robot Walks into a CI Center: What Audiologists Need to Know about iotaSOFT, Including Counseling Tips

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1.  Which of the following is an iotaSOFT robotic-assisted cochlear implant electrode array system feature?
  1. Patient-mounted, thumb-sized robotic insertion device, console, stand and foot pedal
  2. Bedside-mounted, thumb-sized robotic insertion device, console, stand and foot pedal
  3. Patient-mounted, large format robotic insertion device, console, stand and foot pedal
  4. Bedside-mounted, large format robotic insertion device, console, stand and foot pedal
2.  Which of these answers best characterizes the “12-month zero factor” described in the Khan et al 2026 data?
  1. At the 12-month post-activation mark, 29% of the robotic-assisted cohort experienced DOHL, compared to 0% of the manual cohort and showed statistical significance of p=0.011.
  2. At the 12-month post-activation mark, 29% of the robotic-assisted cohort experienced DOHL, compared to 0% of the manual cohort although this was not statistically significant.
  3. At the 12-month post-activation mark, 0% of the robotic-assisted cohort experienced DOHL, compared to 29% of the manual cohort although there was no statistical significance.
  4. At the 12-month post-activation mark, 0% of the robotic-assisted cohort experienced DOHL, compared to 29% of the manual cohort and showed statistical significance of p=0.011.
3.  Which of the following best describes the clinical rationale for using post-operative acoustic thresholds as a "diagnostic proxy" for structural preservation following robotic-assisted cochlear implantation?
  1. Post-operative thresholds measure the electrical impedance of the electrode array to confirm correct scalar placement.
  2. Stable post-operative acoustic thresholds indicate that the elimination of manual insertion transients and pressure peaks has successfully maintained the delicate intracochlear architecture.
  3. Post-operative audiometric markers are used primarily to determine the appropriate MAPping levels for the speech processor’s T-coils.
  4. A reduction in post-operative thresholds suggests that the robotic system has increased the speed of insertion to prevent fibrotic tissue growth.
4.  Based on patient preference data from the University of Iowa Cochlear Implant Program regarding iotaSOFT technology, what was the identified threshold at which a significant majority of patients expressed a willingness to change providers or travel to a different geographic region?
  1. When the traveling distance exceeded 500 miles from their primary residence.
  2. Only if their established provider did not accept their primary health insurance
  3. When the availability of robotic-assisted surgery offered a statistically higher probability of preserving residual hearing compared to manual insertion
  4. Only when the robotic-assisted surgery was offered as part of a clinical trial
5.  The January 2026 FDA 510(k) clearance for the iotaSOFT Insertion System expanded the indication from 12 years and older to 4 years and older, why is the maintenance of residual hearing particularly critical for the expanded pediatric patient population (ages 4 and older)?
  1. Maintaining residual hearing allows the child to continue using high-power bone conduction hearing aids in the implanted ear.
  2. Preservation of the intracochlear environment is a prerequisite for "future-proofing," ensuring the ear remains a viable candidate for emerging technologies or therapies.
  3. The 2026 clearance requires patients to have a minimum of 80% word recognition in the ear to be implanted via robotic assistance.
  4. Robotic insertion is mandatory for pediatric patients because manual insertion is contraindicated by the FDA for children under age 12.