CellScope Oto

Market Suggested Retail Price

$299.00

Distributors / Implementing Organizations

Clinicians and families may purchase the Oto directly from the Cellscope website.

Manufacturing/Building Method

Oto is mass produced by CellScope.

Intellectural Property Type

Trademarked

User Provision Model

Users can obtain the Oto from the product website. There is also an adapter for a standard insufflator bulb (not included).

Distributions to Date Status

Unknown

Design Specifications

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.

Technical Support

CellScope provides FAQ, video vutorials, and instructions on their website, as well as contact information.

Replacement Components

Compatible with standard Welch-Allyn specula

Lifecycle

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

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

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.

Other Information

In order to talk back and forth with doctor, an at-home user must have a network connection (WiFi or cell data)