N/A
N=53
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Hearing Loss, Sensorineural · Hearing Loss, Cochlear · Deafness
Bottom Line
View on ClinicalTrials.gov: NCT02941627 ↗Enrolled (actual)
53
Serious AEs
5.9%
Results posted
Nov 2021
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuro Zti (Device); Neuro One (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oticon Medical
- Primary completion
- Nov 2019
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 | — |
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.
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.