Legal · Medical disclaimer
Medical Disclaimer
Please read this before relying on any result produced by OtoSensAI. This notice explains what the tool can and cannot do, and where your responsibility begins.
OtoSensAI is an AI-assisted screening aid operated by Voxmedai Healthtech Pvt Ltd. It does not diagnose, treat, or replace examination by a licensed medical professional.
Every result must be independently verified by a qualified clinician before any medical decision is made.
1.The AI can be wrong
OtoSensAI's classification of a tympanic membrane image is a statistical prediction, not a clinical finding. It may produce incorrect, incomplete, or misleading results, and its accuracy varies with image quality, lighting, positioning, and pathology that may not be visible in a single photograph.
- It may miss conditions that are present.
- It may suggest conditions that are not present.
- It is a supplementary tool only — never a sole basis for action.
2.Confidence is not correctness
The Service displays a confidence score with every result. It is important to understand what that score does and does not mean.
What confidence is
- How strongly the model favours one label over the alternatives it considered
- A property of the model's internal scoring
- A way of comparing one result against another
What confidence is not
- A probability that the result is correct
- A measure of clinical certainty
- A reason to act, or to refrain from acting
A high-confidence result can still be wrong. Confidence cannot detect pathology the model was never trained to recognise.
A low-confidence result does not rule anything out. It means the model is uncertain — not that the ear is normal.
In both cases the correct response is the same: examine the patient.
3.Verification by a professional is required
Any diagnosis, treatment plan, referral, or reassurance must come from a licensed medical practitioner following a proper clinical examination — not from a result on this screen.
If you are a non-specialist clinician, treat the output as a prompt for further assessment, never as a conclusion. If you are not a clinician, treat it as a reason to seek an appointment, never as an answer.
4.No doctor–patient relationship
Using OtoSensAI does not create a doctor–patient relationship between you and Voxmedai, its founders, or its ENT faculty reviewers. Reviewer comments, where provided, are for quality-assurance and educational purposes connected to the platform, and do not constitute a formal medical opinion, prescription, or diagnosis.
Review is not real-time and may take several days. You must never wait for it before seeking care.
Where a Reviewer identifies a finding suggesting urgent or serious pathology, we will attempt to contact you at your registered email within one working day, advising you to seek in-person specialist assessment promptly.
This is a safety measure, not a diagnosis, and not a service you may rely upon. Absence of contact never indicates absence of pathology.
5.Regulatory status
OtoSensAI is regulated as a software medical device under India's Medical Devices Rules, 2017, as administered by CDSCO.
| Field | Detail |
|---|---|
| Approval | CDSCO market approval — pending Market approval has not been granted. The Service currently operates under CDSCO Form MD-13, Licence No. SW/MD/MD-13/2026/000004207 — a licence to manufacture for the purpose of test. See the Test-Period Disclaimer. |
| Device class | As determined at approval Class B under the current test licence. |
| Approved use | Screening and clinical decision-support aid, subject to independent clinical judgement |
| Manufacturer | Voxmedai Healthtech Pvt Ltd |
The row above describes the intended use at approval. Until market approval is granted, the Test-Period Disclaimer governs: outputs are "not a diagnosis, not a clinical finding, and not authorised decision-support," and no output may be used to direct, delay, alter, or escalate the management of any patient.
The Service is not approved as a standalone diagnostic device, and no result may be treated as a diagnosis. We will update this section, and notify users, if our regulatory classification or approval status changes.
6.Personal information and your images
Do not include patient- or self-identifying information — names, dates of birth, ID or record numbers, contact details, or faces — in any image, filename, or note.
We strip image metadata and discard original filenames automatically at upload, before storage. What we cannot control automatically is what appears inside the frame, or what you type into a notes field. Those remain your responsibility.
Where you have consented, de-identified images are used to improve the AI model. You may decline and still use the Service, and you may withdraw your consent at any time. See Sections 6, 8, and 12 of the Terms & Conditions.
7.Liability
To the maximum extent permitted by law, Voxmedai, OtoSensAI, and their founders, reviewers, employees, and affiliates accept no liability for any decision made in reliance on the tool, nor for any indirect or consequential harm arising from its use. The Service is provided "as is," without warranty of accuracy or fitness for any clinical purpose.
We do not exclude or limit our liability for death or personal injury caused by our negligence, for fraud, or for any other liability that cannot lawfully be excluded.
Our liability is otherwise limited as set out in Section 18 of the Terms & Conditions, and is backed by product liability insurance.
8.In an emergency
Seek immediate in-person medical care for any of the following: severe ear pain; sudden hearing loss; high fever; discharge of blood or pus; dizziness or vertigo; facial weakness; swelling or redness behind the ear; severe headache with ear symptoms; or any rapidly worsening symptom.
Never delay treatment because of a result shown here. A reassuring output is not reassurance.
9.Territorial scope
OtoSensAI is offered in India only, to users located in India, under Indian regulatory approval. It is not offered or supported in any other jurisdiction. A medical device approval is territorial: approval granted by CDSCO authorises the Service in India and confers no authorisation elsewhere.
10.Your acknowledgement
By continuing to use OtoSensAI, you confirm that you have read and understood this disclaimer; that you accept its outputs are not medical advice, are not a diagnosis, and may be wrong; and that you will independently verify any result with a qualified healthcare professional before acting on it.
This disclaimer complements — and does not replace — the Terms & Conditions and the Privacy Policy.
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