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

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.

Study Overview

• Status: Completed
• Conditions: Cochlear Implants; Sensorineural Hearing Loss, Bilateral
• Intervention / Treatment: Device: Mi2000 Totally Implantable Cochlear Implant

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
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège, Department ORL
• Germany
  • Bayern
    • München, Bayern, Germany, 81377
      • Klinikum der Universität München, Campus Großhadern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mi2000 Cochlear Implant surgery; 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.	Device: Mi2000 Totally Implantable Cochlear Implant; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 52 weeks
Speech perception in quiet	Speech perception in quiet will be assessed with a monosyllables test	up to 52 weeks
Speech perception in noise	Speech perception in noise will be assessed with a sentence test in noise	up to 52 weeks
Audiograms	Audiograms will be recorded in unaided and in best aided condition	up to 52 weeks
Impedance Field Telemetry	Impedance Field Telemetry (PIFT)	up to 52 weeks
Auditory Nerve Response Telemetry (ART)	Auditory Nerve Response Telemetry (ART)	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)	up to 52 weeks
Questionnaire on usability of the device	Device use will be assessed using a questionnaire, recording user feedback	up to 52 weeks
Health Utilities Index 2/3 (HUI2/3)	Quality of life will be assessed by the HUI2/3 questionnaire	up to 52 weeks
Speech, Spatial and Qualities of Hearing (12 item version) (SSQ12)	Quality of life will be assessed by hte SSQ12 questionnaire	up to 52 weeks
Nijmegen Cochlear Implant Questionnaire (NCIQ)	Quality of life will be assessed by the NCIQ questionnaire	up to 52 weeks
Sound quality ratings	Subjective rating of sound quality	up to 52 weeks

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH
• Investigators: Principal Investigator: Phillippe Lefebvre, Prof. Dr. med., Centre Hospitalier Universitaire de Liège, ORL; Principal Investigator: Joachim Müller, Prof. Dr. med., Klinikum der Universität München, HNO

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID Numbers: MED-EL_CRD_2014_03

Drug and device information, study documents

• 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