Health TrialsbyHealthPanel

Anatomy-based Fitting in Cochear Implant Users

ConditionsCochlear ImplantOutcomesQuality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario la Paz

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anatomy-based fitting (ABF)

    Procedure/Surgery

    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.

  • Standard Fitting

    Procedure/Surgery

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

  • Standard fitting+ ABF

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Standard fittingPlacebo comparator 1 intervention
Group B: Anatomy-based fittingExperimental treatment 1 intervention
Group C: Within-subject design: Standard fitting + ABFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Result from the speech test in noise (S0N0)

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

Time frame
Month 6
2

Results from speech tests in noise with spatially separated loudspeakers

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

Time frame
Month 6
3

Result from the speech test in quiet (S0)

Speech perception evaluation with CI-only (disyllables)

Time frame
Month 6

Secondary outcomes

1

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.

Time frame
Month 6
2

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.

Time frame
Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Collaborator

Source ClinicalTrials.gov
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