Hearing Implants, Hearing Loss
Conditions
Brief summary
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.
Interventions
DEVICECochlear Nucleus Nexa Cochlear implant (CI1032)
Participants will be implanted with a CI1032 cochlear implant as determined by the treating clinician
DEVICECochlear Nucleus Nexa Cochlear implant (CI1022)
Participants will be implanted with a CI1022 cochlear implant as determined by the treating clinician
DEVICECochlear Nucleus Nexa Cochlear implant (CI1012)
Participants will be implanted with a CI1012 cochlear implant as determined by the treating clinician
Sponsors
Cochlear
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older (at time of consent). * Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted. * Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted. * Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation. * Candidate is a fluent speaker in the language used to assess speech perception performance. * Willing and able to comply with study follow-up schedule. * Willing and able to provide written informed consent. * Candidate has access to a Smartphone compatible with Nucleus Smart App.
Exclusion criteria
* Prior cochlear implantation in the ear to be implanted. * Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator. * Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation). * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child or sibling. * Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. * Women who are pregnant. * Current participation, or participation in an interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean within-participant change in the word recognition score in quiet | Preimplantation to 6 months post-activation | Percent correct word score from preimplantation to post-activation in the implanted ear. Score range: 0 to 100% correct, where a higher score is a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events and device deficiencies | From enrolment to 12 months post-activation | Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency |
| Mean within-participant change in Speech Spatial Qualities questionnaire (SSQ-12) | Preimplantation to 3, 6 and 12 months post-activation | Speech, Spatial and Qualities of Hearing Scale Global Score (SSQ-12). Scores range from 0 to 10, where high scores indicate greater ability (less hearing disability). |
| Mean within-participant change in word recognition score in quiet | Preimplantation to 3 and 12 months post-activation. | Percent correct word score from preimplantation to post-activation in the implanted ear. Score range: 0 to 100% correct, where a higher score is a better outcome. |
| Mean within-participant change in Living with Cochlear implants questionnaire (LivCI) | Preimplantation to 3, 6 and 12 months post-activation | Living with Cochlear Implants Questionnaire (LivCI) evaluates the impact of a hearing device on four domains, Participation (range 0 to 12), Psychosocial \& Wellbeing (range 0 to21), Stigma (range 0 to 15) and Management \& Aesthetics (range 0 to 18), where a higher domain score indicates a positive patient report. |
| Mean within-subject change in speech recognition threshold in noise | 3, 6 and 12 months post-activation | Speech reception threshold for a digit triplet test where 50% of the digits are correctly identified. The score upper limit is 20 dB, with no lower limit. A lower score indicates better performance. |
Countries
Germany
Contacts
CONTACTcltd-prs-admin@cochlear.com PRS Specialist
Outcome results
None listed