Wellness Device: Oralable is not a medical device and is not intended to diagnose, treat, cure, or prevent any disease.
A Beacon Hospital research program is planned. Clinic kits have not yet shipped. The consumer app and hardware remain wellness tools unless and until regulatory clearances apply.
Oralable Gen1 pilot — PCB00003 · PCB REV10 · BOM REV8 · Kaga ES2832AA2 · kits not yet shipped
| Hardware generation | Gen1 (pilot · kits gated) |
| BOM | PCB00003-TGM-BOM-REV8 |
| PCB production / assembly | REV10 pilot (REV8 production data family) |
| Board target (firmware) | pcb00003 · nRF52832 |
| BLE module (U5) | Kaga ES2832AA2 |
| Battery | CG-320B ~15 mAh (typical Gen1 build) |
| Firmware (pilot) | 1.0.85 (minimum 1.0.63 · recommend 1.0.85) |
| Software phase (now) | Vitals Phase 0 (temple HR & SpO₂) |
| Overnight UI (patient app) | State hypnogram (Dashboard + Share) · Clinical Temporalis PDF · bands unlock after ≥1 h worn; aim ≥6 h for a full night view |
| PPG Sensor | MAXM86161 (Analog Devices) |
| PPG Wavelengths | Infrared (880nm), Red (660nm), Green (520nm) |
| Accelerometer | LIS2DTW12 (STMicroelectronics) |
| Accelerometer Range | ±2g, 14-bit resolution |
| Temperature | On-chip sensor |
| PPG (all channels) | 50 Hz |
| Accelerometer | 100 Hz |
| Temperature | 1 Hz |
| Battery | 0.1 Hz |
| Protocol | Bluetooth Low Energy 5.0 |
| Processor | nRF52832 (Nordic Semiconductor) |
| BLE module (U5) | Kaga ES2832AA2 (nRF52832) |
| Range | ~10 meters (typical indoor) |
| Firmware (Gen1 pilot) | 1.0.85 (minimum 1.0.63) |
| Battery | LiPo rechargeable (~15 mAh typical Gen1 build) |
| Runtime | 6-8 hours continuous (typical) |
| Charging | Oralable charging case (USB-C). Seat the clip so the coils align. Not Qi / MagSafe / a phone wireless pad |
| Status LED | Green only. On the case, no phone: flashing green while charging; a short green pulse when hold is reached. Off the case, not connected: dark. Never red or blue |
| Charge Time | ~2 hours (typical) |
| Dimensions | 26.2 × 9.1 × 8.2 mm |
| Weight | ~2 grams |
| Housing | Formlabs Dental LT Clear V2 resin |
| Water Resistance | Splash resistant (not submersible) |
| Primary site (pilot) | Temple / temporalis (Vitals Phase 0 — HR & SpO₂) |
| Worn / dock sensing | Automatic worn = IR pulse (not die temperature). Status LEDs are green-only |
| Muscle-event algorithms | Phase 1+ after vitals gates (clench / IR-DC occlusion research) |
| iOS | iPhone 12 and later, iOS 16+ |
| Android | Not currently supported |
| App | Oralable 4.3.3 (build 5) on the App Store / TestFlight |
| OTA updates | MCUboot / mcumgr via Nordic Device Manager (BLE) |
Gen2 (upcoming — not in pilot kits): new hardware generation — see About · Hardware ↔ BOM map.
| Hardware generation | Gen2 |
| BOM | PCB00003-TGM-BOM-REV9 |
| PCB | REV11 |
| BLE module (U5) | Kaga ES4L15BA1 (nRF54L15) |
| Battery | LP260820 ~30 mAh |
| Firmware (target) | 2.0.x-gen2 (not in pilot kits) |
| App / GATT | Same 50 Hz TGM stream as Gen1 |