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

Not Applicable

Completed

• Conditions: Cochlear Implants; Sensorineural Hearing Loss, Bilateral
• Interventions: Device: Mi2000 Totally Implantable Cochlear Implant

• Registration Number: NCT04571333
• Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH

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 Timeline

• Study Start: 2020-09-07
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mi2000 Cochlear Implant surgery	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.

Primary Outcome Measures

Name	Time	Method
Safety of the study device	up to 16 weeks	Safety of the study device in the intended population will be assessed by an analysis of adverse events (AEs) reported

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Liège, Department ORL; 🇧🇪 Liège, Belgium

Klinikum der Universität München, Campus Großhadern; 🇩🇪 München, Bayern, Germany