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Anatomy-based Fitting in Cochear Implant Users

NCT05360212 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-12

No results posted yet for this study

Summary

In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.

Conditions

  • Cochlear Implant
  • Outcomes
  • Quality of Life

Interventions

PROCEDURE

Anatomy-based fitting (ABF)

MAESTRO 9 can display the tonotopic frequency of each individual electrode channel imported from OTOPLAN to further support fitting based on these measures. The audiologist can set a frequency-band distribution that is more closely aligned to the tonotopic frequency distribution as imported from OTOPLAN.

PROCEDURE

Standard Fitting

These group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9.

PROCEDURE

Standard fitting+ ABF

Patients of this group are both fitting using the standard frequency-band distribution and the anatomy-based frequency distribution in MAESTRO 9. So, subjects will have both study maps on their audio processor throughout the whole study. They will have to change weekly between both fittings: standard fitting and anatomy-based fitting. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    collaborator INDUSTRY

  • Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

    lead OTHER

Principal Investigators

  • Luis Lassaletta, PhD · Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Spain

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 NCT05360212 on ClinicalTrials.gov