| 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
|
|
|
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
|
|
|
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. |