Clinical validation of 4K three-dimensional exoscope system in stapedotomy: a retrospective cohort study - Scorecard - MDSpire

Clinical validation of 4K three-dimensional exoscope system in stapedotomy: a retrospective cohort study

  • By

  • Chaoyue Zhao

  • Bo Gao

  • Guojian Wang

  • Honglei Zhang

  • Xin Zhang

  • Wei Liu

  • Dongyi Han

  • Yongyi Yuan

  • Hang Shao

  • Pu Dai

  • July 3, 2026

  • 0 min

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Clinical Scorecard: Evaluation of the 4K Three-Dimensional Exoscope System in Stapedotomy: A Retrospective Cohort Analysis

At a Glance

CategoryDetail
ConditionStapedotomy
Key MechanismsComparison of 4K three-dimensional exoscope systems (4K3D-ES) versus operative microscope (OM) in surgical procedures.
Target PopulationPatients with conductive hearing loss or mixed hearing loss due to otosclerosis.
Care SettingTertiary referral center

Key Highlights

  • 4K3D-ES demonstrated technical feasibility with no intraoperative conversion to OM.
  • Operative time and intraoperative blood loss were statistically comparable between 4K3D-ES and OM.
  • Both groups achieved significant air-bone gap improvement postoperatively.
  • No major complications were reported, ensuring a strong safety profile.
  • Surgical teams endorsed the ergonomic advantages and image quality of 4K3D-ES.

Guideline-Based Recommendations

Diagnosis

  • Confirmed diagnosis of otosclerosis with preoperative air-bone gap ≥15 dB.

Management

  • Stapedotomy performed using either 4K3D-ES or traditional OM based on surgeon preference.

Monitoring & Follow-up

  • Postoperative audiometric assessments at 2 weeks and follow-up ranging from 0.5 to 12 months.

Risks

  • Transient vestibular symptoms occurred in minimal cases; no major complications such as sensorineural hearing loss.

Patient & Prescribing Data

Patients undergoing stapedotomy for conductive or mixed hearing loss due to otosclerosis.

Both surgical techniques provided equivalent audiological outcomes.

Clinical Best Practices

  • Utilize standardized surgical protocols such as the Fisch technique.
  • Ensure comprehensive surgical documentation with video recordings.
  • Evaluate ergonomic factors for surgical teams to enhance performance.

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