Sensorineural Hearing Loss, BilateralTICINCT04571333
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
A study testing Mi2000 Totally Implantable Cochlear Implant in people with Sensorineural Hearing Loss, Bilateral and Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral, Cochlear Implants
- What is being tested?
- Mi2000 Totally Implantable Cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Centre Hospitalier Universitaire de Liège, Department ORL
Liège, 4000
Germany1 site
Klinikum der Universität München, Campus Großhadern
München, Bavaria, 81377
About this study
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
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.
Read the 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.
- Being tested
- Mi2000 Totally Implantable Cochlear Implant
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mi2000 Totally Implantable Cochlear ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mi2000 Cochlear Implant surgery | Experimental | 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. Receives: Device: Mi2000 Totally Implantable Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 16 weeks
Secondary outcomes (12)
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
Measured: up to 52 weeks
Speech perception in quiet
Speech perception in quiet will be assessed with a monosyllables test
Measured: up to 52 weeks
Speech perception in noise
Speech perception in noise will be assessed with a sentence test in noise
Measured: up to 52 weeks
Audiograms
Audiograms will be recorded in unaided and in best aided condition
Measured: up to 52 weeks
Impedance Field Telemetry
Impedance Field Telemetry (PIFT)
Measured: up to 52 weeks
Auditory Nerve Response Telemetry (ART)
Auditory Nerve Response Telemetry (ART)
Measured: up to 52 weeks
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)
Measured: up to 52 weeks
Questionnaire on usability of the device
Device use will be assessed using a questionnaire, recording user feedback
Measured: up to 52 weeks
Health Utilities Index 2/3 (HUI2/3)
Quality of life will be assessed by the HUI2/3 questionnaire
Measured: up to 52 weeks
Speech, Spatial and Qualities of Hearing (12 item version) (SSQ12)
Quality of life will be assessed by hte SSQ12 questionnaire
Measured: up to 52 weeks
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Quality of life will be assessed by the NCIQ questionnaire
Measured: up to 52 weeks
Sound quality ratings
Subjective rating of sound quality
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start7 Sep 2020
- Primary completion1 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillippe Lefebvre, Prof. Dr. med., Principal investigator, Centre Hospitalier Universitaire de Liège, ORLJoachim Müller, Prof. Dr. med., Principal investigator, Klinikum der Universität München, HNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571333
- Sponsor's protocol ID
- MED-EL_CRD_2014_03
- Acronym
- TICI
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2020
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to small sample size, de-identification of individual patient data is not possible.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04571333
- Acronym / sponsor ID
- TICI / MED-EL_CRD_2014_03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mi2000 Cochlear Implant surgery | Experimental | Device: Mi2000 Totally Implantable Cochlear ImplantDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mi2000 Totally Implantable Cochlear ImplantDuring 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. | Device | Mi2000 Cochlear Implant surgery |
Primary outcome
Safety of the study device
Time frame: up to 16 weeks
Safety of the study device in the intended population will be assessed by an analysis of adverse events (AEs) reported
12 secondary outcomes
Safety of the study device
Time frame: up to 52 weeks
Speech perception in quiet
Time frame: up to 52 weeks
Speech perception in noise
Time frame: up to 52 weeks
Audiograms
Time frame: up to 52 weeks
Impedance Field Telemetry
Time frame: up to 52 weeks
Auditory Nerve Response Telemetry (ART)
Time frame: up to 52 weeks
Hardware and device parameters stored in the internal memory
Time frame: up to 52 weeks
Questionnaire on usability of the device
Time frame: up to 52 weeks
Health Utilities Index 2/3 (HUI2/3)
Time frame: up to 52 weeks
Speech, Spatial and Qualities of Hearing (12 item version) (SSQ12)
Time frame: up to 52 weeks
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Time frame: up to 52 weeks
Sound quality ratings
Time frame: up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No. Due to small sample size, de-identification of individual patient data is not possible.
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Clinical Utility of Residual Hearing in the Cochlear Implant Ear
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A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillippe Lefebvre, Prof. Dr. med. principal investigator
Centre Hospitalier Universitaire de Liège, ORL
Joachim Müller, Prof. Dr. med. principal investigator
Klinikum der Universität München, HNO
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mi2000 Totally Implantable Cochlear Implant in people with Sensorineural Hearing Loss, Bilateral and Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the study device (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.