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Anatomy Based Selection of CI Array for SSD Patients

NCT06189274 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-01-03

No results posted yet for this study

Summary

The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.

Conditions

  • Single-Sided Deafness

Interventions

OTHER

Anatomy-Based Electrode Array Selection

Use of pre-operative imaging to select the appropriate length electrode vs standard of care

OTHER

Standard of Care Electrode Array Selection

Use of standard of care electrode which is the FLEX 28 electrode

Sponsors & Collaborators

  • Med-El Corporation

    collaborator INDUSTRY

  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-10-31
Completion
2025-12-31
FDA Device
Yes

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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 NCT06189274 on ClinicalTrials.gov