HearX STK Tablet-based hearing care solution audiology solution

• (1) Samsung Galaxy A7 Tablet
• (1) Samsung Galaxy A7 Tablet Universal Case
• (1) Sennheiser HD280 PRO Closed, Dynamic Around-the-Ear Monitoring Headphones
• (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. How can the hearX® STK benefit me as an audiologist?

The hearX® STK aims to equip healthcare professionals by providing a solution that allows adult patients to take a hearing test at home, curb-side, or counter-side. This solution provides a low-touch or no-touch alternative to traditional audiometric testing in the booth. The hearX® STK offers a test battery to: refer patients requiring a more comprehensive diagnostic assessment for suspected ear disease and; support hearing aid fitting*.The owner of the hearX STK device remains responsible for adhering to the relevant territory regulations to implement the hearX® STK into their practice.

2. What audiometric tests can be conducted using the hearX® STK? 

The comprehensive solution allows healthcare providers to conduct the following tests towards successful hearing aid fitting in low-or no-touch models of care:

Digital pure tone audiometry using hearTest, a certified CE and FDA registered audiometer (IEC 60645-1) with calibrated headphones offering rapid automated testing. 

Speech-in-noise testing using hearSpeech for a speech recognition threshold and to inform patient care, counseling, and management of hearing aid expectations.

Also includes a UCL/MCL tests component for determining the dynamic reach of patients for hearing aid fitting. The UCL/MCL test duration is a quick and reliable addition to the speech recognition test and corresponds with traditional audiometry testing (refer to the UCL/MCL white paper). 

hearRisk assessment detects the risk of ear disease and is based on

Conductive loss risk algorithm (patent pending) with 95% accuracy;

Asymmetric loss screening; FDA red flag questions. (The CEDRA questionnaire is an optional assessment.)

Optional: If the user has a hearScope device, otoscopy images can be captured and attached to the hearing test results after tests are completed.

3. Is it possible to perform bone conduction audiometry? 

Usually, the diagnostic assessment for a patient with suspected ear disease requires air and bone conduction audiometry, which is required to be performed in a sound-treated room to ensure that reliable thresholds can be measured down to -10 dB HL. The challenge with a Self Test Kit, is that it requires hearing tests in environments that do not always comply with ideal testing environment standards. Apart from the environments not being ideal for bone conduction the challenge further is the ability to self-administer a bone conduction test is somewhat difficult to set up.

The problem that requires a solution is to differentiate patients who require traditional clinic-based services,  i.e. cases with suspected ear disease or conductive hearing loss, from those with sensorineural hearing loss, who are likely candidates for hearing aids. Fortunately, some recent developments provide alternatives to conventional audiological testing, such as bone conduction audiometry and tympanometry, to identify the risk of ear disease. 

We developed our hearRisk product, which provides a proprietary way of detecting conductive hearing loss risk with a 95% accuracy and can be used to flag 3% of patients that can not be fitted with a hearing aid and then if required, ask those patients to visit the clinic. 

The hearX® STK does not offer bone conduction audiometry, but rather offers our hearRisk product. 

We ask certain FDA recommended questions to detect ear disease and also offer the CEDRA questionnaire to detect if specific ear disease conditions are present.

4. How does the pure tone audiometry test, used as part of the hearX® STK compare to pure tone testing conducted in an audiology practice?

The hearTest pure tone audiometry test is a clinically validated CE and FDA registered test and results in various peer-reviewed articles have shown that hearTest provides similar results compared to the golden standard in audiometry. The outcome of this paper, Smartphone threshold audiometry in underserved primary health-care contexts, indicates that accurate air-conduction audiometry can be conducted in a sound booth and without a sound booth. 

A recent article Accuracy and Reliability of Smartphone Self-Test Audiometry in Community Clinics in Low Income Settings: A Comparative Study has also indicated that Smartphone self-test audiometry can provide accurate and reliable air conduction hearing thresholds with sensitivity for detection hearing loss >40?dB HL in one ear was 90.6% (n?=?84 ears), and specificity 94.2% (n?=?84 ears).

For more information on the research related to the hearX® products please visit: https://www.hearxgroup.com/research.

5. Is it possible to add the hearScope digital otoscope to this solution?

Yes, by purchasing the hearScope add-on, the hearX® STK can include the digital video-otoscope to be used by patients at home, as part of curb-side tests, or as part of counter-side testing. The user is guided by a detailed tutorial to take an image of the tympanic membrane to see if there are any obstructions in the ear canal that will hinder hearing aid fitting. The use of the otoscope in-home testing is optional for patients and possible for significant others that may have the dexterity to handle the otoscope can be asked for assistance. The otoscope works with specula that are significantly shorter than other clinical specula to protect the patient’s ear and further improve the ease of use of the otoscope.

6. The hearScope™ otoscope uses AI image classification. Does this mean the audiologist is not involved in the otoscopy?

No, the audiologist remains involved in the entire testing session including the otoscopy. Even though hearScope™ includes the world's first AI image classification system, which instantaneously classifies captured images in the categories of normal, chronic perforation, wax obstruction, or abnormal - which is a high probability of another pathology being present, it is the audiologist or physician's responsibility to interpret the images and decide on a course of action. The information is shown to the patient but is also included as part of the test result with the image to the audiologist asynchronously.

The hearScope™ AI feature is currently in BETA-testing and not certified yet. Use this feature at your own risk. The use of hearScope™ should not replace your good judgment, common sense, or healthcare experience. It is in your best health interest to use the feature in conjunction with medical advice obtained from a qualified healthcare professional, preferably one specializing in diagnosing diseases of the ear. 

7. How can the audiologist make sure his patient is not in a noisy environment while performing the test?

The hearX® STK includes a noise monitoring system and monitors the noise in the environment. We advise via the app if the environment is too noisy and the patient should find a more quiet area for testing area. The testing also uses noise monitoring to pause the test and advise for a restart, if required. Additional quality control measures monitor the response times and false response counts to also indicate the test reliability. All quality measures are available alongside the test results to the audiologist. 

8. How long should I wait before I can access my patients' test results?

As long as the tablet is connected to a Wi-Fi network the test results will be received instantly through a secure cloud service and will be accessible on mHealth Studio Cloud. Test results are therefore accessible asynchronously and the audiogram and all relevant test data for the patient will be available for telesupport services. All data seamlessly integrates with mHealth Studio Cloud data management software.

9. Which devices are compatible with the hearX® STK?

The hearX® STK is sold with a standardized device to ensure the correct outputs are produced for audiometric testing. Only devices procured directly from hearX®, for this purpose, can be used. 

A Samsung Tab A tablet is included with the hearX® STK and adheres to the ANSI S3.6 standards required for a type 4 audiometer. 

10. Where can I use the hearX® STK?

The hearX® Self Test Kit can be used in multiple environments, such as curb-side testing within a drive-through setting, home testing, or even counter-side testing to adhere to the required social distancing measures.

Ensure that you remain familiar and in compliance with all regulations applicable to your practice as they relate to the remote fitting of hearing aid devices. Regulatory requirements in this area of practice are constantly evolving, including with regards to remote medical evaluations and practice of remote care. hearX® makes no warranty or representation as to the Purchaser’s right and allowance to use the Product for its desired purpose, within the territory of use. It remains the Purchaser’s responsibility to adhere to the relevant territory regulations, which include both state and federal regulations.

11. Will my patients know how to use the self-test application?

Yes, the easy step-by-step software will guide patients through a comprehensive hearing assessment. Software checks are included to ensure the headphones are fitted correctly before the test is started and tutorials are added at key points to ensure the patient can easily complete the hearing assessments.

12. Is it possible for the audiologist to get an instantaneous view of the patient’s test results via mHealth Studio Cloud?

Note that a stable internet connection is required to sync test results from the mHealth Studio App to mHealth Studio Cloud. Therefore, test results will only be visible once all tests have synced to the cloud.

13. Is it required to fill in the reference number, when prompted in the hearX® STK application?

Note: The reference number is an optional field and it is possible to be skipped. Should the audiologist not want to request a reference number from the patient, the reference number can be marked as non-required in the mHealth settings. Please refer to the training manual for instructions on how to disable the reference number.

14. Is it possible that patients can see their own test results, as well as other patient’s test results?

It is not possible to view test results related to another patient. After completing the tests, the patient can view his/her simplified test results with a short description.

15. Does the patient keep the tablet and headphones? 

No, the patient returns the kit to the hearing healthcare provider who should then clean and disinfect the headphones and tablet for use with another patient. 

16. Is there a warranty period for my devices? 

Yes, the hearX® STK comes with a 1-year out-of-box warranty. If a device fails within the first year then the supplier warranty applies. The time for the replacement of a smartphone device may take up to 3 months.

17. Are the headphones calibrated and how long is the calibration valid for?

Yes, all headphones need to be calibrated on an annual basis. The calibration status of the headphones is shown on the tablet and a warning is lifted once the headphones are nearing calibration expiry. Once the headphone calibration has expired, the headphones need to be returned to the service center for recalibration. After receiving back the headphones, the calibrated headphones should be re-linked to the tablet and can be used for testing for another 12 month period.

18. Where should my headphones be calibrated?

All headphones should be calibrated at a hearX® calibration facility. Please email hearX® at support@hearxgroup.com or contact the office during business hours (Monday to Friday from 9 am to 4 pm SAST) at US: (415) 212-5500 OR RSA: +27 (0) 12 030 0268, to schedule an appointment.

19. Can I use hearScreen without the mHealth Studio App?

HEARSPEECH

hearSpeech is a comprehensive binaural assessment tool that gauges an individual's ability to identify digits-in-noise, providing valuable insights into speech-in-noise comprehension. This aids in informing patient care, counseling, and managing expectations related to hearing aid functionality.

Additionally, hearSpeech incorporates a UCL/MCL test component, a quick and reliable assessment to determine the dynamic hearing reach of patients for effective hearing aid fitting. The UCL/MCL test aligns with traditional audiometry testing, offering a holistic approach to evaluating and addressing hearing needs.

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 HEARX STK?

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

2023 Renewal Option Costs for hearX STK - Set A:

$830.00  -   Includes Annual Software License Renewal & New Calibrated Headphone (no testing downtime) 

Terms and Conditions apply.