FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101784 [Registered on: 22/01/2026] Trial Registered Prospectively
Last Modified On: 19/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Validation of a remote testing hearing diagnostic audiometer for a hospital 
Scientific Title of Study   earKART OMNI A remote audiometry testing device Validation of a remote testing hearing diagnostic audiometer for hospital and community settings 
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  All India Institute of Medica Sciences, New Delhi 
Address  Office No. 4060, Teaching Block, Department of ENT, All India Institute of Medica Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  01126594922  
Fax    
Email  kapil_sikka@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kapil Sikka  
Designation  Professor 
Affiliation  All India Institute of Medica Sciences, New Delhi 
Address  Office No. 4060, Teaching Block, Department of ENT, All India Institute of Medica Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  01126594922  
Fax    
Email  kapil_sikka@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kapil Sikka  
Designation  Professor 
Affiliation  All India Institute of Medica Sciences, New Delhi 
Address  Office No. 4060, Teaching Block, Department of ENT, All India Institute of Medica Sciences, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  01126594922  
Fax    
Email  kapil_sikka@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  The Indian Council of Medical Research (ICMR), New Delhi 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
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
New Delhi
DELHI 
9810423088

kapil_sikka@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, 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  earKART OMNI (A remote audiometry testing device)  earKART OMNI is a remote audiometry testing device that enables the audiologist to perform audiometry test for the patients who reside in remote areas or are unable to be physically present due to personal limitations. It facilitates the testing to take place with clinician and patient at two different locations. This results in minimized requirement of patient to travel to clinics or hospitals for such medical evaluations. 
Comparator Agent  Grason-Stadler industry (GSI) Clinical Tympanometer  Tympano meter will be used for performing a full range of middle ear measurements on patients of all ages. It is a gold standard device for performing tympanometry, acoustic reflex testing, reflex decay testing, and other diagnostic test. 
Comparator Agent  Grason-Stadler industry (GSI) Dual channel Audiometer  It is a Two channel audiometer, recognized worldwide as the gold standard for performing Pure tone Audiometry, Speech Audiometry and special test (SISI, Tone Decay test etc.)  
Comparator Agent  Neuroaudio (Neurosoft) Otoacoustic Emissions (OAE) testing device  Portable OAE testing device that can record otoacoustic emissions across the hearing frequencies. It can perform both transient OAE (TEOAE) and Distortion product OAE (DPOAE). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adults (more than 18 years) attending the outpatient department (OPD) of ENT Department
2. Individuals giving consent for participation.  
 
ExclusionCriteria 
Details  1. Individuals with active discharge will not be included for tympanometry and OAE testing.
2. Individuals not giving consent for participation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The expected outcome is a comprehensive validation of the earKART OMNI remote hearing testing device in both hospital setting. Deliverables will include a detailed report on the device’s diagnostic accuracy and user-friendliness supported by analytical validation data. Findings will provide essential evidence for potential public health deployment of earKART OMNI device in hearing loss diagnosis.   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 subjects variable degree of Hearing Loss.  All the analysis will be perform at the end of data collection. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/02/2026 
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="0"
Months="6"
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  

The rise in number of cases of disability caused by diseases of the ear and mastoid process mandates timely diagnosis and intervention. Diagnosis is the first and the most important stage of the recovery process. To estimate the hearing abilities of an individual pure tone audiometry is one of the most widely used audiological tests However, timely and accessible testing remains a challenge in low-resource and outreach settings. The conventional audiometers require appropriate sound treated audiological set up and patient’s presence for the testing procedure. It often results in delays and lack of accessibility. The earKART OMNI is a remote audiometry testing device that enables the audiologist to perform audiometry test for the patients who reside in remote areas or are unable to be physically present due to personal limitations. It facilitates the testing to take place with clinician and patient at two different locations. This results in minimized requirement of patient to travel to clinics or hospitals for such medical evaluations. Our study aims to validate the analytical performance of earKART OMNI against the gold standard diagnostic audiometer at a tertiary care hospital. We will evaluate 60 patient samples at AIIMS, New Delhi for analytical accuracy and linearity. The device will be compared with the standard audiometer and tympanometer and audiological test battery such as pure tone audiometry, tympanometry and speech audiometry will be performed. We expect this study to generate validation data for potential clinical deployment of earKART OMNI by assessing the device in terms of linearity and accuracy compared to commercially available device. this will improve accessibility to audiological testing for difficult to test population or subjects with limited mobility. The data collected will be instrumental in refining the device, developing implementation strategies and informing policy decisions for broader adoption.

 
Close