Does turning on a cochlear implant machine during surgery will help kids hear better ? A Study on Hearing and Implant performance on change of approach

Randomized Control Trial to Analyse the Effect of Intra Operative Switch On (IOSO) of Cochlear Implant as Compared To Delayed Switch On of Cochlear Implant On Electrical Impedance Measurement and Auditory Skills Development In Pediatric Patients With Congenital Profound Idiopathic Non-Syndromic SNHL - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082786

Enrollment

Registered

2025-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intra Operative Switch On of the Cochlear Implant: Cochlear Implant device will be switched on during the surgery only , that would take additional 10-15 minutes during the surgery Cont

Eligibility

Inclusion criteria

Inclusion criteria: Pediatric patient between Age 9 Months to 5 years with suitable Candidacy AND Patient with Congenital Idiopathic Profound SNHL planned for Cochlear Implant with caregivers willing for Follow up Of 6 Months

Exclusion criteria

Exclusion criteria: Patient with significant cognitive impairment which may affect speech and language development AND Intraoperative complications during surgery that may preclude IOSO

Design outcomes

Primary

Measure	Time frame
To Compare Electrical Impedance of Cochlear Implant electrodes between patients who undergo IOSO and those with delayed Switch ON (between 2wks-4wks) Timepoint: 6 MONTHS	—

Secondary

Measure	Time frame
To assess the Auditory outcome between two groups using standardized tests to evaluate if IOSO leads to earlier Auditory stimulation leading faster acquisition of auditory skills and speech perception.Timepoint: 6 MONTHS;Impact of early switch ON the battery usage of the implant as compared to delayed switch ONTimepoint: 6 MONTHS;To observe complications related to wound healing for both the groups Timepoint: 6 MONTHS;To assess the cost incurred by the hospital and family of the children and analyze the reduction in financial burden on them as a result of same day switch on.Timepoint: 6 MONTHS	—

Measure

Time frame

To assess the Auditory outcome between two groups using standardized tests to evaluate if IOSO leads to earlier Auditory stimulation leading faster acquisition of auditory skills and speech perception.Timepoint: 6 MONTHS;Impact of early switch ON the battery usage of the implant as compared to delayed switch ONTimepoint: 6 MONTHS;To observe complications related to wound healing for both the groups Timepoint: 6 MONTHS;To assess the cost incurred by the hospital and family of the children and analyze the reduction in financial burden on them as a result of same day switch on.Timepoint: 6 MONTHS

—

Countries

India

Contacts

Public ContactDr Prem Sagar

AIIMS New Delhi

sagardrprem@gmail.com8130069892

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026