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Q&A: In-ear portable EEG system eases access for neurology diagnoses
Key takeaways:
- The portable in-ear EEG aims to integrate real-time brain activity data into daily life.
- Medical consultation is required once appropriate data is collected.
The need to rapidly, accurately and faithfully transmit brain wave activity via electroencephalogram when a specialist cannot be seen in a timely manner is a significant unmet need in clinical neurology.
One solution is a noninvasive, portable and wearable in-ear electroencephalogram (EEG) device for patients aged 6 years and older that allows for transmission of such data remotely and in real time.Healio spoke with Marc Vaillaud, MD, clinical innovations director at Paris-based Naox Technologies, to find out more about the potential of this new platform to enable faster consultations with doctors while working toward smoother diagnoses of neurology-based conditions.
Healio: What was the impetus behind creating an EEG that is both portable and adjustable?
Vaillaud: Naox was launched with a dual objective: to democratize access to EEG everywhere, including medically underserved areas, and to enable simple, long-term monitoring by integrating EEG into daily life, ultimately making AI available for brain data to prevent neurological disease.
Healio: Are there any other similar devices made by other companies and, if so, what distinguishes Naox’s device?
Vaillaud: The wearable EEG sector is gaining significant momentum, with various companies exploring different form factors such as headbands, around-the-ear, or in-ear devices. Currently, there are approximately four teams worldwide working specifically on in-ear EEG. However, Naox stands out for two primary reasons:
- Regulatory status: We are the first and only in-ear solution to have received FDA clearance for medical-grade EEG. This is our strongest differentiator, validating our data quality for clinical use.
- Scalability and fit: While some competitors focus on custom-molded earpieces for each subject, we prioritize scalability. Our device uses standardized earbuds with small, medium and large generic tips, making deployment immediate and logistics much simpler than custom solutions.
Healio: How does the EEG system work?
Vaillaud: Patients, users or any health care professional can place the earbuds of the Naox device in the ears. The sensors, which contain dry electrodes on their tips, are positioned in the ear canals, while the data captured is transmitted wirelessly or saved in the device in a standard EEG format.
Healio: Is there a specific condition the EEG targets, or is it a tool for recognizing any potential neurological issue?
Vaillaud: NAOX in-ear EEG was cleared as a tool to acquire, record and transmit electrical activity of the brain via a single-channel EEG. The medical use of data acquired is to be performed under the direction and interpretation of a licensed medical professional, who decides in which cases it should be used.
Healio: How does the in-ear EEG system’s performance compare to other EEG platforms?
Vaillaud: This was one of the central points of our FDA submission. We demonstrated that the in-ear signal from our device is highly comparable to the signal obtained from the low temporal electrodes derivation of a standard scalp EEG.Therefore, our device delivers performance equivalent to the clinical gold standard for these specific areas.
Healio: Once the data is recorded and transmitted, how does the patient interact with a clinician or specialist to gain a diagnosis?
Vaillaud: A medical consultation is required. The physician will either access the data on a secured platform locally or remotely, for interpretation if he is a certified neurophysiologist, or access the data with a report validated by a certified neurophysiologist.
Healio: Could you describe how patients would receive these devices? For example, would the doctor provide them during an office visit and then the patient would return the device at the next visit?
Vaillaud: Yes, the primary workflow involves the doctor prescribing the device for a specific duration based on clinical need. The patient receives the kit during an office visit and returns it once the monitoring period is complete.Additionally, we envision an “EEG stethoscope” model for hospital settings. In this scenario, doctors would carry their own device to perform immediate, spot-check monitoring on patients at the bedside whenever necessary.
Healio: Would patients need to be trained in its placement and use? Who would provide this training?
Vaillaud: Training is minimal and happens at the point of care. When the doctor hands the device to the patient, they will provide a quick demonstration on how to insert and activate it. We have designed the device with a heavy focus on user experience to ensure it is intuitive. It features only two buttons and clear LED status indicators, eliminating the complexity usually associated with EEG setup.
Healio: Are there any other requirements for proper utilization, like power or software?
Vaillaud: No additional tools or complex equipment are required for utilization. We designed the device to be fully standalone. Regarding power, it utilizes a standard USB-C port, so it can be charged easily just like any standard consumer electronic device.
For more information:
Marc Vaillaud, MD, can be reached on LinkedIn here.
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