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

Primary Purpose

Sensorineural Hearing Loss, Bilateral, Cochlear Implants

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mi2000 Totally Implantable Cochlear Implant
Sponsored by
MED-EL Elektromedizinische Geräte GesmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Sensorineural Hearing Loss, Bilateral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Liège, Department ORL
  • Klinikum der Universität München, Campus Großhadern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mi2000 Cochlear Implant surgery

Arm 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.

Outcomes

Primary Outcome Measures

Safety of the study device
Safety of the study device in the intended population will be assessed by an analysis of adverse events (AEs) reported

Secondary Outcome Measures

Safety of the study device
Safety of the study device in the intended population will be assessed by an analysis of adverse events (AEs) reported
Speech perception in quiet
Speech perception in quiet will be assessed with a monosyllables test
Speech perception in noise
Speech perception in noise will be assessed with a sentence test in noise
Audiograms
Audiograms will be recorded in unaided and in best aided condition
Impedance Field Telemetry
Impedance Field Telemetry (PIFT)
Auditory Nerve Response Telemetry (ART)
Auditory Nerve Response Telemetry (ART)
Hardware and device parameters stored in the internal memory
Readout of device parameters stored in the devices internal memory (e.g. log files, battery status, charging status, usage times)
Questionnaire on usability of the device
Device use will be assessed using a questionnaire, recording user feedback
Health Utilities Index 2/3 (HUI2/3)
Quality of life will be assessed by the HUI2/3 questionnaire
Speech, Spatial and Qualities of Hearing (12 item version) (SSQ12)
Quality of life will be assessed by hte SSQ12 questionnaire
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Quality of life will be assessed by the NCIQ questionnaire
Sound quality ratings
Subjective rating of sound quality

Full Information

First Posted
September 9, 2020
Last Updated
April 5, 2022
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04571333
Brief Title
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
Acronym
TICI
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MED-EL Elektromedizinische Geräte GesmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Bilateral, Cochlear Implants

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mi2000 Cochlear Implant surgery
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Mi2000 Totally Implantable Cochlear Implant
Intervention 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.
Primary Outcome Measure Information:
Title
Safety of the study device
Description
Safety of the study device in the intended population will be assessed by an analysis of adverse events (AEs) reported
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Safety of the study device
Description
Safety of the study device in the intended population will be assessed by an analysis of adverse events (AEs) reported
Time Frame
up to 52 weeks
Title
Speech perception in quiet
Description
Speech perception in quiet will be assessed with a monosyllables test
Time Frame
up to 52 weeks
Title
Speech perception in noise
Description
Speech perception in noise will be assessed with a sentence test in noise
Time Frame
up to 52 weeks
Title
Audiograms
Description
Audiograms will be recorded in unaided and in best aided condition
Time Frame
up to 52 weeks
Title
Impedance Field Telemetry
Description
Impedance Field Telemetry (PIFT)
Time Frame
up to 52 weeks
Title
Auditory Nerve Response Telemetry (ART)
Description
Auditory Nerve Response Telemetry (ART)
Time Frame
up to 52 weeks
Title
Hardware and device parameters stored in the internal memory
Description
Readout of device parameters stored in the devices internal memory (e.g. log files, battery status, charging status, usage times)
Time Frame
up to 52 weeks
Title
Questionnaire on usability of the device
Description
Device use will be assessed using a questionnaire, recording user feedback
Time Frame
up to 52 weeks
Title
Health Utilities Index 2/3 (HUI2/3)
Description
Quality of life will be assessed by the HUI2/3 questionnaire
Time Frame
up to 52 weeks
Title
Speech, Spatial and Qualities of Hearing (12 item version) (SSQ12)
Description
Quality of life will be assessed by hte SSQ12 questionnaire
Time Frame
up to 52 weeks
Title
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Description
Quality of life will be assessed by the NCIQ questionnaire
Time Frame
up to 52 weeks
Title
Sound quality ratings
Description
Subjective rating of sound quality
Time Frame
up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillippe Lefebvre, Prof. Dr. med.
Organizational Affiliation
Centre Hospitalier Universitaire de Liège, ORL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joachim Müller, Prof. Dr. med.
Organizational Affiliation
Klinikum der Universität München, HNO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Liège, Department ORL
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Klinikum der Universität München, Campus Großhadern
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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