This product has been discontinued.
The CellScope Oto device is a smartphone otoscope system that includes an attachment to convert a standard smartphone into a digital otoscope with data transmission capabilities. Requires CellScope Oto Mobile App to record & share images and/or videos of the ear canal.
Market Suggested Retail Price
Distributors / Implementing Organizations
Clinicians and families may purchase the Oto directly from the Cellscope website.
The Oto is an optical attachment that transforms an iPhone into a digital otoscope. The device includes an insufflator port for pneumatic otoscope and uses LEDs. The device is primarily intended for use in children as ear infections are most prevalent in children under 7 years of age, although reusable tips come in custom sizes for all ages Accessories include:
- - Phone Cases - iPhone 5/5s/SE full case and iPhone 6/6s quarter case ensure secure attachment of Oto to iphone (Note: not compatible with iPhone 5c, 6Plus, 6sPlus, 7 or 7Plus)
- - Specula - 4 reusable ear tips in adult and infant sizes. The Oto is also compatible with Welch Allyn Specula
- - Travel Case - Allows device to be stowed for transport
- - CellScope Companion App - Oto for Clinicians companion app is designed to allow user to capture, view, and share high quality magnified images of the tympanic membrane.
CellScope provides FAQ, video vutorials, and instructions on their website, as well as contact information.
Compatible with standard Welch-Allyn specula
While a traditional otoscope can last several years, with changing iPhone sizes and phones often being upgraded or changed yearly, the lifecycle of an Oto may be much shorter.
Manufacturer Specified Performance Parameters
Provide diagnostic solutions at the same rate as any digitally enhanced microscope in a well-equipped hospital
Vetted Performance Status
Physicians can diagnose otitis media equally well with either modality (traditional otoscope or the oto), and thought the images from the oto were more than adequate for diagnosing otitis media
Safety instructions are provided with purchase.
Complementary Technical Systems
The Seymour Application for viewing the inside of the ear and communication with doctors.
Academic Research and References
Douglas Kamerow, Regulating medical apps: which ones and how much?, BMJ 2013, 347
Kathryn M. Rappaport, C. M. McCracken and J. Beniflah, Assessment of a Smartphone Otoscope Device for the Diagnosis and Management of Otitis Media, Clinical Prediatrics 2016 Voll 55(9) 800-810
JR Patrick, How mHealth will spur consumer-led healthcare, MHealth Journal, July 2015
Lynne Shallcross, Mobile Health: Apps for every age and ouch, May 2015
Kate Stephenson, Claude Laurent, OPEN ACCESS GUIDE TO AUDIOLOGY AND HEARING AIDS FOR OTOLARYNGOLOGISTS
Compliance with regulations
Oto is HIPPA compliant. The Oto’s status as a Class 1 device exempts it from FDA approval or clearance (Source: 21 CFR Parts 862-892) due to the low-risk level associated with this type of device. CellScope adheres to the FDA’s rules and requirements for marketing, including but not limited to: registration, labeling and good manufacturing practices.
In order to talk back and forth with doctor, an at-home user must have a network connection (WiFi or cell data)