SHOEBOX Audiometry

Target SDGs

Target Users (Target Impact Group)

Community, Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Clearwater Clinical Limited, Grand Challenges Canada, Business Development Bank of Canada, World Wide Hearing.

Manufacturing/Building Method

Software development.

Intellectural Property Type

Patent

User Provision Model

The iPad application can be downloaded from the Apple Store. Contact SHOEBOX Audiometry to register for a free 14 day trial. SHOEBOX Audiometery has partnered with World Wide Hearing's Hearing Express Program to distribute the product. The Hearing Express Program aims to train locals on how to test people’s hearing and provide mobile hearing care kits so that these trained individuals can screen and diagnose hearing loss within their communities. World Wide Hearing works with manufacturers such as Clearwater Clinical to drive down costs associated with of materials. Clearwater charges World Wide Hearing (at a heavily discounted rate) and WWH does not charge for where they donate the unit.

Distributions to Date Status

SHOEBOX Audiometry has over 500 customers in 40 countries Interview with representative

Design Specifications

SHOEBOX requires an iPad, customized software, and calibrated headphones to operate. The ShoeBOX Audiometer creates a Conditioned Play Audiometry (CPA) test where the user plays an interactive listening game that involves touching items on the iPad screen that make sounds. Precise hearing thresholds across all sound frequencies for each ear are recorded as the user plays the game to produce an audiogram. SHOEBOX uses a modified veresion of the gold standard Hughson-Westlake protocol to determine thresholds.The ShoeBOX Audiometry technology automatically adjusts test protocols for masking, ambient noise, and response reliability. The system can generate pure tone or warble tone stimulus and features narrow band noise for masking. The system is available in three versions, Clinical, diagnostic, and screening. Shoebox Clinical includes additional clinical capabilities required for audiologists and otolaryngologists. Shoebox also features an integrated patient database for adding notes to any patient file and built-in questionnaires to capture patient history. The system includes a HIPAA-compliant web portalthat can be used on any web browser to access, manage, and export hearing test results and patient data. Additional technical specifications include: - Device(s) required: iPad Air, iPad Mini, or iPad Pro - Operating system and version: iOS 8.0 or later - Languages available: English, Esperanto, French, German, Vietnamese - Sound generation: 250–8000 Hz, 10–90 dB HL, 0–115 dB HL (Pro edition) - Accuracy: +/- 1 dB - Preventative maintenance: annual calibration of headphones More information can be found here

Product Schematics

Technical Support

The manufacturer provides every new user one complimentary hour of “Getting Started” training. Users can receive customized on-site or web-based training for an additional cost. The manufacturer also provides a customer service package that includes annual calibration, a Shoebox Cloud account, ongoing technical support (via email, chat, phone, or web), and software upgrades. The customer service package is free for the first year and is available for an additional charge thereafter. Purchase of the SHOEBOX Audiometer includes a one year warranty. Clearwater provides full technical support and training and the one-year warranty includes a calibration and a new pair of headphones every year. ^{Interview with representative} Calibration of new headphones is offered by ShoeBox. To maintain compliance with ANSI S3.6 standards, ShoeBox offers the following services: - annual notification of when calibration is due - automatic swap out of newly calibrated transducers - return shipment for old transducers - new calibration certificate for ANSI records management

Replacement Components

N/A

Lifecycle

An iPad's lifespan is approximately 3 years

Manufacturer Specified Performance Parameters

To develop a highly portable and cost-efficient solution to diagnosing hearing loss at a young age.

Vetted Performance Status

A performance study conducted in a remote region in Canada¹ and Uganda diagnosed 139 out of 868 children with hearing loss when using the SHOEBOX Audiometer. A study conducted with 49 participants (44 adults, 5 children) indicated that the results from the SHOEBOX Audiometer were within 10 dB of those determined by conventional audiometry for 164 of 172 hearing levels and did not show proportional bias over the testing range.² Additionally, a clinical study with 85 consecutive patients revealed that there was no statistically significant difference between thresholds obtained by SHOEBOX and traditional audiometry.³

Safety

General iPad safety guidelines can be found here

Complementary Technical Systems

Otoscopes, hearing aids.

Academic Research and References

Compliance with regulations

SHOEBOX Audiometry is listed as a Class II device by the FDA and Health Canada. The device conforms to current ANSI, OSHA and CSA requirements. SHOEBOX is both HIPAA & ISO compliant.

Evaluation methods

Clinical validation studies

Other Information

SHOEBOX Audiometry is a recipient of the Grand Challenges Canada award. SHOEBOX Audiometry also won an award for the best technolgoical innovation for care delivery at the Canadian Association of Pediatric Health Centers Innovation Showcase. Contact ShoeBox for a free trial.