An observational study in Hearing Loss, Binaural and Cochlear Implantation, sponsored by MED-EL Elektromedizinische Geräte GmbH. Not yet recruiting at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by MED-EL Elektromedizinische Geräte GmbH · Observational
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI. This PMCF investigation will collect retrospective and prospective clinical data from the use of the Mi2000 TICI and related devices.
This PMCF investigation is performed on a new cochlear implant system, which was previously studied in two pre-market clinical investigations with limited follow-up duration. The purpose of the current clinical investigation is to collect further evidence by collecting clinical data on the use of the Mi2000 TICI.
The Mi2000 TICI is a state-of-the-art cochlear implant, designed to be totally implantable, indicated to treat severe to profound hearing loss, asymmetric hearing loss and single-sided deafness.
This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 36 is below the median of 100 across 192 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →MED-EL Elektromedizinische Geräte GmbH is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Anything that, in the opinion of the Investigator, would
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recipients of a MED-EL Mi2000 TICI UNICO in a previous clinical investigation.
Device: Cochlear Implantation
Participants in this clinical investigation received a totally implantable cochlear implant and will be followed-up for an extended period of time.
Word Test in Quiet
Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes
Time frame: Pre-op to 36 months after first fitting
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Disease specific Quality of Life, overall score is on a scale from 0 to 100, higher numbers indicating better outcomes
Time frame: Pre-op to 36 months after first fitting
Speech, Spatial, Quality of Hearing (SSQ12)
Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes
Time frame: Pre-op to 36 months after first fitting
Word test in quiet
Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes
Time frame: through study completion, an average of 60 months after first fitting
Sentence Test in Noise
Oldenburg Matrix Test, results measured in dB signal-to-noise ratio (SNR) with a range of +30 to -10 dB SNR, lower values indicating better outcomes
Time frame: through study completion, an average of 60 months after first fitting
Health Utility Index Mark 3 (HUI3)
Health utility scale: 1.00: Perfect health. 0.00: Death. Negative values: States worse than death.
Time frame: through study completion, an average of 60 months after first fitting
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Disease specific Quality of Life, overall score is on a scale from 0 to 100, higher numbers indicating better outcomes
Time frame: through study completion, an average of 60 months after first fitting
Speech, Spatial, Quality of Hearing (SSQ12)
Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes
Time frame: through study completion, an average of 60 months after first fitting
Hearing Implant Sound Quality Index (HISQUI)
Sound quality score ranging from 19 (very poor sound quality) to 133 (very good sound quality)
Time frame: through study completion, an average of 60 months after first fitting
Tinnitus functional index (TFI)
Tinnitus questionnaire measures the severity and negative impact of tinnitus on a 0 (Not a Problem / Slight Tinnitus) to 100 (Very Big Problem / Very Severe Tinnitus) scale
Time frame: through study completion, an average of 60 months after first fitting
Audiogram
Pure-tone air-conduction hearing thresholds will be measured in each ear. The threshold is the lowest sound level, in decibels hearing level (dB HL), at which the participant responds. The outcome is the threshold at each frequency. Higher thresholds mean poorer hearing; lower thresholds better hearing.
Time frame: through study completion, an average of 60 months after first fitting
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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MED-EL Elektromedizinische Geräte GmbH