Anatomy-based Fitting in Cochear Implant Users

NCT05360212 | Recruiting

• 1 other identifier: PI-6128
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Result from the speech test in noise (S0N0)

  Speech perception evaluation with CI-only (MATRIX) with signal and noise in the same channel

  Month 6

• Results from speech tests in noise with spatially separated loudspeakers

  Speech perception evaluation with CI-only (MATRIX) with signal and noise in different channels

  Month 6

• Result from the speech test in quiet (S0)

  Speech perception evaluation with CI-only (disyllables)

  Month 6

Secondary Outcomes (2)

• Results of quality of sound

  Month 6

• Results of quality of life in challenging situations

  Month 6

Study Arms (3)

Standard fitting

PLACEBO COMPARATOR

The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9

Procedure: Standard Fitting

Anatomy-based fitting

EXPERIMENTAL

In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9

Procedure: Anatomy-based fitting (ABF)

Within-subject design: Standard fitting + ABF

EXPERIMENTAL

The third group constitutes the within-subject design. These subjects 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.

Procedure: Standard fitting+ ABF

Interventions

Anatomy-based fitting (ABF) PROCEDURE

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.

Anatomy-based fitting

Standard Fitting PROCEDURE

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

Standard fitting

Standard fitting+ ABF PROCEDURE

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.

Within-subject design: Standard fitting + ABF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
• Post-OP CT scan of the CI electrode available
• Subject implanted with MED-EL cochlear implant(s)
• Subjects received a Flex28 or FlexSoft electrode
• Subject planned to receive a SONNET 2 /RONDO3 audio processor on the newly implanted side
• Audio processor not yet activated on the newly implanted side
• The most apical active electrode contact has to be inserted at least 450°
• Minimum of 10 active channels can be activated
• Fluent in Spanish
• Signed and dated ICF before the start of any study-specific procedure
• % speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side
• Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)
• SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB
• Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB

You may not qualify if:

• EAS user (user of an EAS audio processor)
• Implanted with C40+, C40X and C40C
• Implanted with an ABI or Split electrode array
• Known allergic reactions to components of the investigational medical device
• Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz: lead
• MED-EL Elektromedizinische Geräte GesmbH: collaborator

Study Sites (1)

Hospital Universitario de La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Study Officials

• Luis Lassaletta, PhD

  Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Lassaletta, PhD

CONTACT

0034656898265; llasaletta@salud.madrid.org

Miryam Calvino, PhD

CONTACT

0034646354267; miryamcf@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 4, 2022
• Study Start: March 11, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)