Clinical validation of 4K three-dimensional exoscope system in stapedotomy: a retrospective cohort study
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By
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Chaoyue Zhao
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Bo Gao
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Guojian Wang
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Honglei Zhang
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Xin Zhang
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Wei Liu
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Dongyi Han
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Yongyi Yuan
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Hang Shao
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Pu Dai
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July 3, 2026
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Clinical Scorecard: Evaluation of the 4K Three-Dimensional Exoscope System in Stapedotomy: A Retrospective Cohort Analysis
At a Glance
| Category | Detail |
| Condition | Stapedotomy |
| Key Mechanisms | Comparison of 4K three-dimensional exoscope systems (4K3D-ES) versus operative microscope (OM) in surgical procedures. |
| Target Population | Patients with conductive hearing loss or mixed hearing loss due to otosclerosis. |
| Care Setting | Tertiary 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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