Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.

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Brief Title

Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.

Official Title

Feasibility Study: A Totally Implantable Cochlear Implant (Mi2000) for Electrical Stimulation of the Auditory Pathway of Adults With Severe to Profound Sensorineural Hearing Loss

Brief Summary

      This clinical investigation aims to collect data on the use of the Mi2000 system, a totally
      implantable cochlear implant system, for the first time in human subjects.
    

Detailed Description

      Cochlear implants (CI) provide a large majority of recipients with a significant degree of
      speech understanding. However, CI systems rely on external parts, namely Behind-the-Ear (BTE)
      audio processors with coils or single-unit processors to function. This can have several
      disadvantages: for instance, the hardware is exposed to external trauma and to the effects of
      head movement and gravity. The device is also put at risk by humid, dusty, or dirty
      conditions as well as by physical activities that lead to water exposure such as swimming or
      sports in general (e.g. perspiration).

      In addition, some patients are concerned with the cosmetic appearance of the external parts
      which are visible (more so than modern behind-the-ear hearing aids), something that may not
      be desirable to many potential candidates.

      This clinical investigation aims to collect data on the use of the Mi2000 system, a totally
      implantable cochlear implant system, for the first time in human subjects.
    


Study Type

Interventional


Primary Outcome

Safety of the study device

Secondary Outcome

 Safety of the study device

Condition

Sensorineural Hearing Loss, Bilateral

Intervention

Mi2000 Totally Implantable Cochlear Implant

Study Arms / Comparison Groups

 Mi2000 Cochlear Implant surgery
Description:  During the surgery visit, the Mi2000 Cochlear Implant will be implanted according to the general surgical guidelines and the Mi2000 specific surgical guidelines under general anaesthesia.

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

6

Start Date

September 7, 2020

Completion Date

March 1, 2022

Primary Completion Date

July 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Minimum age of eighteen (18) years at time of enrolment

          -  Bilateral sensorineural hearing loss with no or limited benefit from a hearing aid
             (>70 dB HL PTA4)

          -  Post-lingual onset of deafness

          -  No or limited benefit from hearing aids for less than 10 years.

          -  A maximum score of 50% on a monosyllables test in the language of the test centre in
             the ear to be implanted

          -  General health condition, psychological and emotional condition deemed compatible with
             the treatment and tests performed in this study and realistic expectations, as deemed
             appropriate by the implanting surgeon/implant board

          -  Fluency in the test language with excellent proficiency, as appropriate to perform
             speech testing

          -  Evidence of up-to-date vaccinations against meningitis, as per recommendations by the
             applicable national body

          -  Signed and dated informed consent before the start of any study-specific procedure

        Exclusion Criteria:

          -  Lack of compliance with any inclusion criterion

          -  Previously having received an implant on the location chosen for placing the cochlear
             implant

          -  Having received a hearing implant from another manufacturer than MED-EL on the
             contralateral ear

          -  Pre-existing condition known to necessitate MRI scans after implantation of the Mi2000

          -  Women being pregnant or nursing

          -  Women of child-bearing age not reporting to use effective contraception

          -  Contraindication to surgery in the middle and inner ear

          -  Contraindication to general anaesthesia

          -  Cochlear malformations, ossification or other obliteration of the cochlea, history of
             meningitis preventing placement of the electrode array, as confirmed by medical
             examination

          -  Acute cholesteatoma

          -  Acute external or middle ear infections

          -  Perforated tympanic membrane

          -  Known intolerance to any of the materials used for the implant or accessories

          -  Non-functional auditory nerve and/or upper auditory pathway including a history of
             vestibular schwannoma

          -  Factors preventing appropriate placement of the stimulator housing and the microphone,
             including fixation with screws, in the bone of the skull

          -  Unstable Meniere's disease, Auditory Neuropathy, Epilepsy not responding to treatment

          -  Unrealistic expectations of the subject

          -  Permanent inability and/or unwillingness to participation in post-operative care and
             rehabilitation

          -  Known intellectual disability and/or psychological diseases

          -  Participation in other pharmacological clinical trials within four weeks prior to
             enrolment
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Phillippe Lefebvre, Prof. Dr. med., +43577885549, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04571333

Organization ID

MED-EL_CRD_2014_03


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

Phillippe Lefebvre, Prof. Dr. med., Principal Investigator, Centre Hospitalier Universitaire de Liège, ORL


Verification Date

September 2020