Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)

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 and an expectedbenefit from cochlear implantation

• A maximum score of 50% on a word test in the language of the test centre in the earto be implanted in the best aided condition

• Fluency in the test language with excellent proficiency, as appropriate to performspeech testing

• Functional auditory nerve

• General health condition, psychological and emotional condition deemed compatiblewith the treatment and tests performed in this study

• Pre-operative assessment according to the local professional standards

• Candidate is highly motivated and has realistic expectations about the expectedbenefit of the implant and shall understand the importance of returning to theimplant centre for regular speech processor programming, assessment sessions andtraining

• Realistic expectations, as deemed appropriate by the implanting surgeon/implantboard

• Evidence of up-to-date vaccinations against meningitis, as per recommendations bythe 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 thecochlear implant

• Having received a hearing implant from another manufacturer than MED-EL on thecontralateral ear

• Pre-existing condition known to necessitate MRI scans after implantation of theMi2000 TICI

• Women being pregnant or nursing

• Women of childbearing age not reporting to use effective contraception

• The individual is known to be intolerant of the materials used in the implant orother required accessories including medical grade silicone, parylene C, titanium,platinum iridium, platinum, stainless chromate steel, thermoplastic elastomere (TPE-S), thermoplastic elastomere (SEBS), mixture of polycarbonate andacrylonitrile-butadiene-styrol polymer (PC/ABS), polyamide, liquid crystal polymer,silicone and polyurethane-coated silicone rubber)

• Absence of cochlear development

• The cause of deafness is non-functionality of the auditory nerve and/or the upperauditory pathway

• Medical contra-indications to middle ear and/or inner ear surgery, and/oranaesthesia

• External or middle ear infections are present

• The tympanic membrane is perforated in the ear to be implanted

• Anatomic abnormalities are present that would prevent appropriate placement of thestimulator housing in the bone of the skull, or prevent placement of the chosenelectrode array into the cochlea (including ossification of the cochlea)

• The psychological status of the individual is unstable

• The individual has unrealistic expectations

• Acute cholesteatoma

• History of vestibular schwannoma

• Unstable Meniere's disease

• Auditory Neuropathy

• Epilepsy not responding to treatment

• Permanent inability and/or unwillingness to participation in post-operative care andrehabilitation

• Known intellectual disability and/or psychological diseases

• Participation in other pharmacological clinical trials within four weeks prior toenrolment

• Anything that, in the opinion of the Investigator, would place the subject atincreased risk; preclude the subject's full compliance with or completion of thestudy