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RECRUITING
NCT05360212
NA

Anatomy-based Fitting in Cochear Implant Users

Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

View on ClinicalTrials.gov

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.

Official title: Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-03-11

Completion Date

2026-12-31

Last Updated

2025-08-12

Healthy Volunteers

Yes

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.

Locations (1)

Hospital Universitario de La Paz

Madrid, Madrid, Spain