Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting

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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