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

Phase 3

Recruiting

• Conditions: Other specified diseases of innerear,

• Registration Number: CTRI/2019/11/021968
• Lead Sponsor: SOCIETY FOR BIOMEDICAL TECHNOLOGY

Brief Summary

Sensory neural hearing loss is a major clinical problem encountered in pediatric and adult population. Cochlear implantation is now an established and well accepted mode of rehabilitation of profound deaf around the world. However due to high cost of implant many patients are unable to afford it. An indigenous affordable cochlear implant system has been developed under the aegis of society for biomedical technology to benefit the needy population. The device needs to be subjected to multi-centric human trials to evaluate safety and efficacy in subjects with profound sensoryneural hearing loss. The primary outcome in terms of improvement in hearing and speech development will be measured during the followup period.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-11
• Last Update Posted: 2019-12-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IMPROVEMENT IN HEARING	12 months
IMPROVEMENT IN SPEECH PERCEPTION	12 months

Secondary Outcome Measures

Name	Time	Method
IMPROVED OVERALL COMMUNICATION ABILITY	IMPROVED CONFIDENCE AND SOCIAL INTERACTIONS

Trial Locations

Locations (5)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES; 🇮🇳 South, DELHI, India

APOLLO HOSPITALS; 🇮🇳 Bangalore, KARNATAKA, India

CHRISTIAN MEDICAL COLLEGE; 🇮🇳 Vellore, TAMIL NADU, India

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION & RESEARCH; 🇮🇳 Chandigarh, CHANDIGARH, India

SRI RAMACHANDRA MEDICAL COLLEGE; 🇮🇳 Chennai, TAMIL NADU, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

🇮🇳South, DELHI, India

PROF ALOK THAKAR

Principal investigator

9999755916

drathakar@gmail.com