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Hearing and Structure Preservation Via ECochG

NCT06268340 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-01-06

No results posted yet for this study

Summary

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

Conditions

  • Hearing Loss, Sensorineural
  • Severe-to-profound Hearing Loss

Interventions

PROCEDURE

ECochG monitored CI surgery incl. corrective action guide

Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide

PROCEDURE

Routine CI surgery without ECochG monitoring

Routine CI surgery with access to ECochG monitoring by surgeon

Sponsors & Collaborators

  • Advanced Bionics AG

    lead INDUSTRY

Principal Investigators

  • Matt E Smith, Dr · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268340 on ClinicalTrials.gov