"This collaboration with Extra Horizon further reinforces our health data security by providing a flexible backend framework, while complying with the regulatory standards for Software as a Medical Device."
Naox Technologies is a French medtech company bringing clinical-grade brain monitoring out of the hospital and into everyday life. Their in-ear EEG (electroencephalography) platform uses miniaturised electrode arrays embedded in earbuds to deliver medical-grade brain signal quality in a wearable form factor — enabling long-duration, real-world neurological monitoring that was previously only possible in a clinical setting.
Over three billion people worldwide are affected by neurological, mental, or sleep-related disorders. Yet access to EEG monitoring remains constrained by the complexity, cost, and discomfort of traditional electrode caps and clinical environments. Naox is solving this with two complementary products:
- NAOX LINK — the world’s first FDA-cleared in-ear EEG medical device, designed for clinical neurology, epilepsy monitoring, and sleep diagnostics. Clinical-grade signal quality validated through peer-reviewed research.
- NAOX WAVE — a plug-and-play EEG platform for integration into True Wireless earbuds, delivering consumer-facing brain biomarkers including concentration, relaxation, and cognitive state tracking.
The challenge
Building a wearable EEG device that qualifies as a Software as a Medical Device requires solving a layered set of engineering, regulatory, and data infrastructure challenges simultaneously. EEG signals are highly sensitive; any degradation in signal quality or data integrity can undermine clinical validity. At the same time, capturing, transmitting, and storing neurological patient data demands a backend that meets the strict requirements of HIPAA, GDPR, and applicable SaMD regulations.
As Naox scaled from prototype to a commercially viable regulated product, they needed a compliant, scalable cloud backend capable of handling continuous, high-frequency EEG data streams — without diverting their engineering team away from sensor hardware and signal processing, which represent the core of their IP.
Why Extra Horizon
Naox chose Extra Horizon’s Medical Backend-as-a-Service as the cloud infrastructure underpinning their NAOX LINK platform. The partnership provided:
- Secure neurological data handling — EEG streams processed and stored in a GDPR and HIPAA-compliant environment
- Real-time data pipelines — enabling low-latency delivery of brain biomarkers from device to clinician dashboard
- Scalable multi-device architecture — built to accommodate growing deployment across hospitals, sleep clinics, and neurology departments
- Reduced regulatory burden — Extra Horizon’s pre-certified infrastructure allowed Naox to focus their resources on EEG signal fidelity and clinical validation
The result
With Extra Horizon as their backend partner, Naox achieved a major regulatory milestone and is advancing clinical adoption of their platform globally.
- FDA cleared — NAOX LINK is the world’s first FDA-authorised in-ear EEG device
- Clinical-grade signal quality validated through published peer-reviewed studies
- Applications across neurology, epilepsy, sleep disorders, and cognitive health monitoring
- B2B platform (NAOX WAVE) enabling OEM integration of brain biomarkers into consumer earbuds