Anatomy-based Fitting in Cochear Implant Users

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Cochlear Implant; Outcomes
• Intervention / Treatment: Procedure: Standard Fitting; Procedure: Anatomy-based fitting (ABF); Procedure: Standard fitting+ ABF

Detailed Description

In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9. The performance with anatomy-based fitting is assessed by comparing performance with the CI in these two groups over time.

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. Here, the performance with anatomy-based fitting is assessed by comparing performance with standard fitting and anatomy-based fitting.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luis Lassaletta, PhD; Phone Number: 0034656898265; Email: llasaletta@salud.madrid.org
• Study Contact Backup: Name: Miryam Calvino, PhD; Phone Number: 0034646354267; Email: miryamcf@yahoo.com

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario de La Paz
    • Contact: Miryam Calvino; Email: miryamcf@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Specific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2/RONDO3 audio processor on the first ear implanted

• 40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side

• 40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion

  • 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

Exclusion Criteria:

• Lack of compliance with any inclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard fitting; The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9	Procedure: Standard Fitting; These group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9.
Experimental: Anatomy-based fitting; 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); 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.
Experimental: Within-subject design: Standard fitting + ABF; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of quality of sound	Subjective results through Hearing Implant Sound Quality Index 19. Scores range 19-133 points. Higher scores mean a better outcome.	Month 6
Results of quality of life in challenging situations	Subjective results through Listening effort questionnaire. Scores range 21-93 points. Higher scores mean a better outcome.	Month 6

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Collaborators: MED-EL Elektromedizinische Geräte GesmbH
• Investigators: Principal Investigator: Luis Lassaletta, PhD, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PI-6128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No