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CTRI Number  CTRI/2025/02/081114 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Screening 
Study Design  Other 
Public Title of Study   Testing of low cost Hearing screening device 
Scientific Title of Study   HearIT - A low cost hearing screening device 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kapil Sikka 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  4060, Department of ENT, Teaching Block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9810423088  
Fax  01126594922  
Email  kapil_sikka@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kapil Sikka 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  4060, Department of ENT, Teaching Block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9810423088  
Fax  01126594922  
Email  kapil_sikka@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kapil Sikka 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  4060, Department of ENT, Teaching Block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9810423088  
Fax  01126594922  
Email  kapil_sikka@yahoo.com  
 
Source of Monetary or Material Support  
The Indian Council of Medical Research (ICMR) Ansari Nagar, New Delhi India Pin Code-110029 
 
Primary Sponsor  
Name  ICMR 
Address  The Indian Council of Medical Research (ICMR), Ansari Nagar New Delhi, India Pin Code-110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kapil Sikka  All India Institute of Medical Science  Room No. 613, 6th Floor, New Raj Kumari Out patient department, Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Science, Ansari Nagar, New Delhi
South
DELHI 
9810423088

kapil_sikka@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Hearing 
Patients  (1) ICD-10 Condition: H908||Mixed conductive and sensorineuralhearing loss, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hear IT, Hearing screening device  The device will be used to perform hearing screening test non-invasively in the mentioned population during the course of the study. HearIT is a DPOAE (Distortion-Product Otoacoustic Emissions) based hearing screening device. It is a hearing screening tool that uses sound to evaluate the health and function of the inner ear. Any individual with minimal training shall be able to operate the device. After initial calibration, the probe is inserted in subject’s ear canal firmly and the test will be run automatically by the system. The assessment will be a one time assessment wherein the evaluation will be performed once in each individual and the values obtained will be compared with the values of standard device. 
Comparator Agent  Neuro Audio, Hearing screening device  It is a standard device currently being used for screening the individuals for hearing deficits in hospitals and medical set ups. It includes standard tests such as Otoacoustic emissions (OAE) and Automated auditory brainstem responses (AABR). The test that will be performed for the present study is Distortion product Otoacoustic emissions (DPOEA). The DPOAEs will be performed on all the subjects once using this device and the Hear IT device each and the values obtained will be compared. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Individual with and without Hearing loss within the specified age range  
 
ExclusionCriteria 
Details  Patients Not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is to determine the signal to noise ration and percentage of individuals passing or failing the screening test with experimental and standard devices. Subsequently, it will be employed to calculate sensitivity, specificity, positive predictive value, and negative predictive value.  The outcomes of both the devices will be evaluated at the end of data collection. 
 
Secondary Outcome  
Outcome  TimePoints 
The Secondary outcome of the study will be comparative values of sensitivity, specificity, positive predictive & negative predictive values using both the devices in different age groups.  All the analysis will be perform at the end of data collection.  
 
Target Sample Size   Total Sample Size="614"
Sample Size from India="614" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hearing impairment is one of the serious disabilities but is often neglected in India. The individual with hearing loss in the country often suffer due to lower wages and inadequacy of facilities for them. This causes more financial burden and higher unemployment rate. The neonatal hearing screening (NHS) programme is universally recommended and accepted means for early identification and intervention of congenital hearing loss. Initially targeted for babies at high risk, Universal Neonatal Hearing Screening (UNHS) now stands for arrangement of, screening every neonate born in the hospital. The implementation of UNHS has been shown to reduce the age of identification of hearing impairment significantly and minimize the overall effect of hearing loss on an individual’s life. In India, the programme implementation is still in initial phase and monitoring children as well as adults regularly is almost non-prevalent. This can be majorly attributed to currently available expensive hearing screening devices. Further, such equipment may only be used by specialists such as audiologists, who are in shortage. In this project we will completely re-engineer such a screening device in order to significantly bring down its cost, enable it to be used by laypersons in the same manner that we use blood pressure monitors or thermometers and make suitable for use in different surroundings without requiring a no-ambient noise setting. More widespread availability of low-cost screening devices will enable their usage in schools, small healthcare centres, factories and construction sites. This in turn will help with the detection of hearing impairment and the affected individuals may be referred for treatment early on, thereby significantly improving the chances of recovery and prevent further deterioration.

 
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