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

NCT04571333 | Completed

• 1 other identifier: MED-EL_CRD_2014_03
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 2

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.

Conditions

Sensorineural Hearing Loss, Bilateral; Cochlear Implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Safety of the study device

  up to 52 weeks

• Speech perception in quiet

  up to 52 weeks

• Speech perception in noise

  up to 52 weeks

• Audiograms

  up to 52 weeks

• Impedance Field Telemetry

  up to 52 weeks

Study Arms (1)

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.

Device: Mi2000 Totally Implantable Cochlear Implant

Interventions

Mi2000 Totally Implantable Cochlear Implant DEVICE

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.

Mi2000 Cochlear Implant surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (2)

Centre Hospitalier Universitaire de Liège, Department ORL

Liège, 4000, Belgium

Location

Klinikum der Universität München, Campus Großhadern

München, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Phillippe Lefebvre, Prof. Dr. med.

  Centre Hospitalier Universitaire de Liège, ORL

  PRINCIPAL INVESTIGATOR

• Joachim Müller, Prof. Dr. med.

  Klinikum der Universität München, HNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 1, 2020
• Study Start: September 7, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); BE (1)