CellScope Oto

Cellscope

This product has been discontinued.

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and product description

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.

Target region(s) Target region for distribution/implementation (listed by country if specified)

United States, but international markets are in the horizon. World Wide Hearing has field tested the Oto in Honduras and Guatemala.

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

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

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

$299 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

LED Otoscope. Many are in development stage but have yet to hit the market.

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Ensure healthy lives and promote well-being for all at all ages

Target user(s) Target user/consumer base (country, income segment)

Trained clinicians or families using the Seymour Application

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

Oto is mass produced by CellScope.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Trademarked and patented

User Provision Model Where can the product be purchased/acquired by end users?

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

Distribution to date Number of units that have been deployed, downloads or users to date

Unknown

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Consumables

Specula (tips)

Power supply type

Continuous, recharging only, none, other

iPhone battery

Indispensable equipment for function

iPhone 5, 5s, SE, 6 or 6s

Maintenance or calibration required by user at time of use? (Y/N)

Target population (age range)

<18 years

Supported testing types

Unknown

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

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.

Product schematics Design and assembly illustrations

Not available

Technical support Technical support provided by

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

Replacement components Availability of replacement components (in-country, by order,...)

Compatible with standard Welch-Allyn specula

Lifecycle Disposal and warranty

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 targets Designer / Manufacturer specified targets

Provide diagnostic solutions at the same rate as any digitally enhanced microscope in a well-equipped hospital

Vetted performance Findings of manufacturer evaluations or independent testing centers

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

Testing organizations Independent lab, academic research centers, etc.

CellScope, Atlantic Pediatric Device Consortium

Safety Potential hazards / risks related to operation of this product

Safety instructions are provided with purchase.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

The Seymour Application for viewing the inside of the ear and communication with doctors.

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

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 Product certifications and standards referenced by designer/manufacturer

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.

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

Manufacturer cites satisfaction among doctors and families as evaluation criteria.

Other information

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

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

Snapshot

Product description Brand name and product description

This product has been discontinued.

Target region(s) Target region for distribution/implementation (listed by country if specified)

United States, but international markets are in the horizon. World Wide Hearing has field tested the Oto in Honduras and Guatemala.

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

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

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

$299 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

LED Otoscope. Many are in development stage but have yet to hit the market.

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Ensure healthy lives and promote well-being for all at all ages

Target user(s) Target user/consumer base (country, income segment)

Trained clinicians or families using the Seymour Application

Manufacturing & delivery

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

Oto is mass produced by CellScope.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Trademarked and patented

User Provision Model Where can the product be purchased/acquired by end users?

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

Distribution to date Number of units that have been deployed, downloads or users to date

Unknown

Performance & use

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Consumables

Specula (tips)

Power supply type

Continuous, recharging only, none, other

iPhone battery

Indispensable equipment for function

iPhone 5, 5s, SE, 6 or 6s

Maintenance or calibration required by user at time of use? (Y/N)

Target population (age range)

<18 years

Supported testing types

Unknown

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

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.

Product schematics Design and assembly illustrations

Not available

Technical support Technical support provided by

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

Replacement components Availability of replacement components (in-country, by order,...)

Compatible with standard Welch-Allyn specula

Lifecycle Disposal and warranty

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 targets Designer / Manufacturer specified targets

Provide diagnostic solutions at the same rate as any digitally enhanced microscope in a well-equipped hospital

Vetted performance Findings of manufacturer evaluations or independent testing centers

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

Testing organizations Independent lab, academic research centers, etc.

CellScope, Atlantic Pediatric Device Consortium

Safety Potential hazards / risks related to operation of this product

Safety instructions are provided with purchase.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

The Seymour Application for viewing the inside of the ear and communication with doctors.

Research & standards

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

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 Product certifications and standards referenced by designer/manufacturer

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

Manufacturer cites satisfaction among doctors and families as evaluation criteria.

Other information

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

Feedback

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

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In context photographs (0)

In context files & documents (0)

Feedback from users, customers & distributors