Clinical trial NCT05360212: Anatomy-based Fitting in Cochear Implant Users
Official title: Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cochlear Implant
Outcomes
Quality of Life
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Sponsor class: OTHER
Collaborators: name: MED-EL Elektromedizinische Geräte GesmbH
First posted: 2022-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Result from the speech test in noise (S0N0)
timeFrame: Month 6
measure: Results from speech tests in noise with spatially separated loudspeakers
timeFrame: Month 6
measure: Result from the speech test in quiet (S0)
timeFrame: Month 6
Secondary outcomes:
measure: Results of quality of sound
timeFrame: Month 6
measure: Results of quality of life in challenging situations
timeFrame: Month 6
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
Study officials:
affiliation: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
name: Luis Lassaletta, PhD
role: PRINCIPAL_INVESTIGATOR
References: