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Clinical Trials of Indian Cochlear Implant system SRAVAN to evaluate for effectiveness in improving hearing in patients with severe to profound hearing loss

Multi-centric clinical trials of SRAVAN Indian Cochlear Implant system indigenously developed by DRDO

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021968
Enrollment
50
Registered
2019-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H838- Other specified diseases of innerear

Interventions

Intervention1: COCHLEAR IMPLANT: Cochlear Implant is an electronic device implanted into the inner ear to improve hearing perception. The device consists of Implantable Receiver Stimulator (IRS) and E

Sponsors

SOCIETY FOR BIOMEDICAL TECHNOLOGY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INDIVIDUALS WITH PRE-LINGUAL OR POST-LINGUAL SEVERE TO PROFOUND SENSORI-NEURAL HEARING LOSS WITH NO BENEFIT FROM HEARING AIDS

Exclusion criteria

Exclusion criteria: 1. DEAFNESS DUE TO LESIONS OF ACOUSTIC NERVE OR OF CENTRAL AUDITORY PATHWAY 2. ABSENCE OF COCHLEAR DEVELOPMENT OR ABNORMAL COCHLEAR ANATOMY 3.ABSENCE OF COCHLEAR NERVE ON MRI 4. TYMPANIC MEMBRANE PERFORATIONS AND ACTIVE MIDDLE EAR INFECTIONS 5. POST MENINGITIS COCHLEAR OSSIFICATION

Design outcomes

Primary

MeasureTime frame
IMPROVEMENT IN HEARING IMPROVEMENT IN SPEECH PERCEPTION Timepoint: 12 months

Secondary

MeasureTime frame
IMPROVED OVERALL COMMUNICATION ABILITY IMPROVED CONFIDENCE AND SOCIAL INTERACTIONSTimepoint: 24 MONTHS

Countries

India

Contacts

Public ContactDR V BHUJANGA RAO

SOCIETY FOR BIOMEDICAL TECHNOLOGY

contact@sbmtindia.org9845042719

Outcome results

None listed

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