HearX hearTest Clinical Pure-Tone Tablet-Based Audiometer with Extended High Frequencies - Set C

• (1) Samsung Galaxy A7 Tablet
• (1) Samsung Galaxy A7 Tablet Universal Case
• (1) RadioEar DD450 High Frequency Circumaural Headphones
• (1) Universal DAC Adapter for IP30/DD450/DD45 (adapter & cable)
• (1) hearX Universal Hard Case
• (1) Year hearTest Software Subscription with Unlimited Test Credits
• (1) Year Warranty on All Hardware Components
• Access to mHealth Studio Cloud Software (Secure cloud-based data management platform)
• Access to Online Training Platform & Remote Technical Support

1. Can the hearTest protocols be changed? 

• Yes, in hearTest, users have the ability to create custom protocols for their frequency tests. They can define the frequency test range within the software, using the HD280 headphones for a range of 125 Hz to 8000 Hz, and the DD450 headphones in combination with the DAC for a range of 125 Hz to 16000 Hz, including the Extended High-Frequency (EHF) range. This allows users to tailor the protocols according to their specific requirements and utilize the appropriate headphones and equipment for their desired frequency testing 

2. Can hearTest be used on any device? 

• No, hearTest cannot be used on any device. While commercially available, off-the-shelf hardware for the solution is used, the smart device used for hearTest is specifically standardized to meet industry standards. This ensures that the device's output, which generates pure tones for the screening test, can be accurately calibrated at specific intensities. This calibration is crucial to ensure that the decibel levels are consistent and reliable. Moreover, the headphones used in hearTest also need to be calibrated according to industry standards to ensure accurate sound reproduction during the testing process. To ensure accurate and dependable results, it is recommended to use the designated, standardized hardware provided by hearX® rather than personal devices.

3. Does hearTest comply with all standards?

• hearTest complies with the following international standards: 

1. IEC 60645-1 - Equipment for pure-tone audiometry (type 4 audiometer)
2. ANSI S3.6 - Specification for audiometers (type 4 audiometer)
3. ISO 8253-1 - Pure-tone air conduction audiometric test methods
4. ISO 389 series - Reference zero for the calibration of audiometric equipment
5. EN 60645-1- The harmonized standard
6. EN ISO 13485- Medical devices - Quality management systems
7. IEC 60601-1-2- Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
8. EN ISO 14971- Medical devices - Application of risk management to medical devices
9. EN 62366-1- Medical Devices - Part 1: Application of usability engineering to medical devices
10. IEC 62304- Medical devices - Software life cycle processes
11. ISO 14155- Clinical investigation of medical devices for human subjects - Good clinical practice      

4. Does hearTest allow testing at 0dB?

• Yes, hearTest does allow for testing at 0 dB and down to -10 dB on the RadioEar DD450 when used in conjunction with the DAC hardware. This means that users can perform frequency tests with sound intensity levels ranging from 0 dB down to -10 dB using the specified hardware setup. 

5. Can hearTest be used outside a booth?

• Yes, hearTest can be used outside of a soundproof booth. It is classified as a certified type 4 audiometer, which means it is suitable for conducting hearing screenings in various environments. However, it is important to note that the user is responsible for ensuring that the test environment complies with relevant local standards. 

6. Can I use hearTest without the mHealth Studio App?

• No, hearTest cannot be used without the mHealth Studio App. It is designed to be used specifically within the mHealth Studio App, along with other related applications such as hearScreen®, hearTest Occ Health, Vula Vision, and the hearX Self Test Kit. The mHealth Studio App serves as the platform for accessing and utilizing these applications effectively. The hearScope is the only product that can be used either within the mHealth Studio App or as a stand-alone application

WHAT IS MHEALTH STUDIO?

 A patient data management tool facilitating data capturing, referral management and secure real-time data monitoring.

mHealth Studio is hearX’s data management portal which is included for free with subscriptions of clinical or screening products. The portal facilitates secure communication and syncing between the hardware solution and the mHealth web portal, allowing you to view all patients and test data online for easy monitoring and management.

mHealth Studio App is a mobile interface for patient data capturing and management. The ecosystem design facilitates access to all mHealth solutions in an easy-to-use manner.

mHealth Studio Cloud is an electronic health record (EHR) web portal for online data management, asynchronous telehealth capabilities, referral management, report generation, data download, and bulk patient uploads to enable secure real-time data monitoring and efficient result management.

HOW DOES MHEALTH STUDIO WORK?

1. Subscription:  Get a subscription to hearX's clinical or screening products.  This includes access to the mHealth Studio portal for free.

2. Hardware Solution:  Use hearX's hardware solution for patient testing, like hearing screening or clinical assessments.

3. Data Collection:  During tests, the hardware collects patient and test data.

4. Syncing:  The data collected by the hardware is securely synced with the mHealth Studio web portal.  This ensures that all patient information and test results are safely uploaded to a centralized system.

5. Online Access:  You can now access all patient records and test data online through the mHealth Studio portal.  This allows for easy monitoring and management of patient information.

6. Secure Communication:  The portal ensures secure communication between the hardware and the online platform, protecting patent confidentiality. 

7. Convenience:  With mHealth, you can efficiently manage patient data and gain insights, making it a valuable tool for healthcare professionals.

ARE THERE ANNUAL FEES FOR THE HEARTEST?

Yes, annual reoccurring maintenance for the hearTest includes Software License Renewal and Headphone Calibration.

2023 Renewal Option Costs for hearTest - Set C:

$690.00  -   Includes Annual Software License Renewal & Annual Headphone Calibration where device is sent out for calibration (testing downtime will occur)

$1,540.00  -   Includes Annual Software License Renewal & New Calibrated Headphone (no testing downtime) 

Terms and Conditions apply.