CellScope Oto Smartphone Otoscope (Discontinued)
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An otoscope attachment that clipped onto a dedicated iPhone case and used the phone camera and app to record ear-canal images and video. Sold in a home version for parents (with remote physician consultations) and a clinician version.
Discontinued. Product reported discontinued; company acquired in 2019.
Key facts
| Product | CellScope Oto (Oto HOME / Oto Clinic) |
|---|---|
| Manufacturer | CellScope, Inc. (acquired October 2019, acquirer undisclosed) |
| Intended users | Professional and home use |
| US FDA status | Exempt (Class I/II exempt) |
| Market status | Discontinued |
Main features
- Smartphone attachment for specific iPhone models (iPhone 5/5s era cases)
- LED illumination; clinician version had insufflator port for pneumatic otoscopy
- Home version included 'Eardrum Finder' positioning guidance
- Oto Connect remote consultation service (launched in California, Dec 2014)
Connectivity
iPhone app; uploads via Wi-Fi/cellular for remote review.
AI and analysis software
The manufacturer does not describe built-in AI for this device. Because its data can leave the device, it can in principle feed separate analysis software; any such software is a distinct product with its own regulatory status.
Regulatory status in the United States
This device type is exempt from FDA premarket notification (no 510(k) required). Class I device, FDA-registered, exempt from 510(k).
Related guide: Digital Otoscope AI Built-In.
Sources
Profile verified against public sources in October 2026. Trademarks belong to their owners.
