N/A
Completed N=53
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Hearing Loss, Sensorineural · Hearing Loss, Cochlear · Deafness
Source: ClinicalTrials.gov NCT02941627 ↗
Enrolled (actual)
53
Serious AEs
5.9%
Results posted
Nov 2021
Primary outcomePrimary: Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants. — 51.5 percent change words correctly repeated
Summary
The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants. |
51.5 | — |
| PRIMARY Major Related Adverse Event (AE) |
1; 1; 2 | — |
| SECONDARY Clinical Benefit on English-speaking Participants |
26; 29; 30; 2; 3; 2 | — |
| SECONDARY Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants |
13.3; 55.8; 64.8; 70.1 | — |
| SECONDARY Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants |
13.3; 43.8; 52.3; 57.6 | — |
| SECONDARY Minor Adverse Events (AE) |
16; 20; 31 | — |
Eligibility Criteria
Inclusion criteria
- Adults, eighteen (18) years of age or older.
- Bilateral severe-to-profound sensorineural hearing loss, defined by pure-tone average (PTA) ≥70 dB HL (Hearing Level) at 500, 1000 and 2000 Hz on both ears.
- HINT sentences recognition scores in quiet ≤ 50% correct, in the best-aided listening condition.
- Post-lingual onset of deafness.
- Primary implantation (no re-implantation).
- Up-to-date pneumococcal vaccine.
Exclusion criteria
- Medical conditions that contraindicate undergoing cochlear implant surgery (middle ear diseases i.e. AOM/CSOM (Acute Otitis Media/Chronic Suppurative Otitis Media) , lesions of auditory nerve, pathologies of central auditory pathway, otosclerosis; cochlear malformation i.e. Mondini malformation, cochlear ossification, large vestibular aqueduct).
- Unrealistic expectations regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and medical device.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
Data sourced from ClinicalTrials.gov (NCT02941627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.