Sensorineural hearing loss indicated for cochlear implantation
Conditions
Interventions
Experimental arm: Standard CI surgery plus a combined workflow of (i) pre-operative CT-based cochlear morphometry/length estimation with CIMAGo, (ii) intraoperative electrocochleography monitoring wit
Sponsors
Nishimura Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults: Patients >=18 years who meet the 2017 Japanese Society of Otorhinolaryngology-Head and Neck Surgery (JSO-HNS) adult CI candidacy criteria: i) Unaided three-frequency PTA (0.5/1/2 kHz) >=90 dB HL; or ii) Unaided PTA 70-=90 dB HL; or ii) If the above cannot be confirmed, after >=6 months of optimal HA use, aided PTA does not improve beyond 45 dB HL; or iii) If the above cannot be confirmed, after >=6 months of optimal HA use, best-aided speech discrimination score =1 year or body weight >=8 kg. However, for cases where the Pediatric Cochlear Implant Indication Criteria (2022) state that surgical indication should be carefully evaluated for patients aged 1 year or older weighing less than 8 kg, the attending physician and the study coordinator shall discuss the safety and scientific validity of including such patients in this study and determine eligibility on a case-by-case basis. Consent: Written informed consent from the participant (and/or legally authorized representative for minors), prior to any trial-specific procedures.
Exclusion criteria
Exclusion criteria: (1)Inner-ear malformation with modiolar deficiency. (2)Any condition that the principal/sub-investigator judges inappropriate for participation. (3)Previously enrolled and treated within this trial. (4) When active inflammation of the middle ear, such as otitis media, is present. (5) When imaging studies fail to identify a suitable site for cochlear implant insertion within the cochlea. (6) When uncontrollable cerebrospinal fluid leakage is anticipated due to severe inner ear malformation. (7) When severe dementia, psychiatric disorders, central auditory processing disorders, or similar conditions make it unlikely that cochlear implantation will provide effective auditory compensation. (8) Other cases where the principal investigator or study coordinator determines that participation in this study would significantly impact the assessment of safety or efficacy, based on criteria in the pediatric/adult cochlear implant eligibility guidelines that require careful consideration of eligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome (EN): Hearing Preservation (HP)- at Week 4 (primary time point) | — |
Secondary
| Measure | Time frame |
|---|---|
| Aided performance Intraoperative ECochG metrics Electrode position metrics Adverse events Plan-Actual deviation between pre-op CIMAGO plan and post-op measurements | — |
Contacts
Public ContactShujiro Minami
National Hospital Organization Tokyo Medical Center
Outcome results
None listed