Brief Title
Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting
Official Title
Comparison of an Anatomy-based Fitting and a Conventional Fitting in Newly Implanted Cochlear Patients. Prospective Monocentric Randomized Double-blind Crossover Study.
Brief Summary
Main objective:
Compare the recognition of environmental sounds with an anatomy-based fitting and with a
default fitting adult patients newly implanted with a MED-EL cochlear implant.
Secondary objectives:
Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting
in adult patients newly implanted with a MED-EL cochlear implant.
Compare speech recognition in noise with an anatomy-based fitting and with a default fitting
in adult patients newly implanted with a MED-EL cochlear implant.
Detailed Description
Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness,
restoring speech perception and verbal communication when the traditional hearing aid no
longer provides satisfactory hearing gain. A cochlear implant includes an electrode array and
its functioning is based on the principle of cochlear tonotopy: each electrode encodes a
frequency spectrum according to its position in the cochlea (high frequencies are assigned to
the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus
breaks down the frequency spectrum into a number of frequency bands via bandpass filters
corresponding to the number of electrodes in the implant. During the fitting these bands can
be modified by the audiologist. The fitting software developed by the manufacturers proposed
a default fitting with a lower limit between 100 and 250 Hz according to the brands and an
upper limit of about 8500 Hz. The frequency bands assigned to each electrode follow a
logarithmic scale with the high frequencies for the basal electrodes and the low frequencies
for the apical electrodes. This distribution takes into account the number of active
electrodes but does not take into account the anatomy and the natural cochlear tonotopy
specific to each patient. Several studies have analyzed the anatomical variations of the
cochlear dimensions: size of the cochlea and the ratio between the contact surfaces of the
electrodes with the cochlea are variable from one patient to another. The insertion depth
during surgery is also variable due to parameters related to the patients as well as to the
operator, which seems to impact the understanding of speech in noise. Mathematical algorithms
have recently been developed to estimate the cochlear tonotopy of each patient from a CT scan
assessment. CT imaging of the implanted ear combined with 3D reconstruction software,
provides cochlear length measurements Using this approach it is possible to measure the
position of each electrode relative to the cochlear apex. Recently, MED-EL (Austria) has
developed a new approach based on CT-scan and tuning of the frequencies associated with each
electrode using anatomical information of position of the electrodes in the cochlea: this
fitting is called anatomy-based fitting.
Main objective:
Compare the recognition of environmental sounds with an anatomy-based fitting and with a
default fitting adult patients newly implanted with a MED-EL cochlear implant.
Secondary objectives:
Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting
in adult patients newly implanted with a MED-EL cochlear implant.
Compare speech recognition in noise with an anatomy-based fitting and with a default fitting
in adult patients newly implanted with a MED-EL cochlear implant.
Plan of the study:
It is a prospective open monocentric randomized crossover study: measures will be done on the
patient at 6 weeks and 12 weeks post-activation.
Study Type
Interventional
Primary Outcome
Recognition of Environmental sounds
Secondary Outcome
Speech recognition in quiet
Condition
Sensorineural Hearing Loss, Bilateral
Intervention
anatomy-based fitting then default fitting
Study Arms / Comparison Groups
Cochlear Implant (CI) with default fitting then anatomy-based fitting
Description: Cochlear Implant with default fitting first during 6 weeks then with anatomy-based fitting during 6 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
24
Start Date
February 15, 2022
Completion Date
August 15, 2023
Primary Completion Date
August 15, 2023
Eligibility Criteria
Inclusion Criteria:
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
Exclusion Criteria:
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Damien Bonnard, Dr, 603592974, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT05230498
Organization ID
MEDEL_anatfit_Bordeaux_study
Responsible Party
Sponsor
Study Sponsor
MED-EL Elektromedizinische Geräte GesmbH
Study Sponsor
Damien Bonnard, Dr, Principal Investigator, University Hospital, Bordeaux
Verification Date
April 2022