hearX®Self Test Kit

The hearX Self Test Kit 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 Self Test Kit offers a test battery to:

1. Refer patients requiring a more comprehensive diagnostic assessment for suspected ear disease and;
2. Support hearing aid fitting.

The owner of the hearX Self Test Kit device remains responsible for adhering to the relevant country-specific regulations to implement the hearX® Self Test Kit into their practice.

The comprehensive self-test solution empowers healthcare providers to conduct a range of assessments essential for successful hearing aid fitting within low- or no-touch models of care:

• Digital Pure Tone Audiometry: Utilizing hearTest, a certified CE and FDA registered audiometer (IEC 60645-1), equipped with calibrated headphones for swift automated testing.
• Speech-in-Noise Testing: Leveraging hearSpeech to determine speech recognition thresholds, providing crucial insights for patient care, counseling, and hearing aid management.
• UCL/MCL Tests Component: Includes a component for assessing the dynamic range of patients, facilitating informed decisions during hearing aid fitting. The UCL/MCL test, known for its efficiency and reliability, complements traditional audiometry testing (refer to the UCL/MCL white paper for further details).
• hearRisk Assessment: Detects the risk of ear disease through:
  • A conductive loss risk algorithm (proprietary software) boasting a 95% accuracy rate.
  • Screening for asymmetric loss.
  • Utilizing FDA red flag questions. (Optional: The CEDRA questionnaire serves as an additional assessment tool.)
• Optional Feature: For users equipped with a hearScope device, otoscopy images can be captured and appended to hearing test results upon completion of assessments.

No, the hearX STK solution does not have bone conduction capabilities. Traditionally, diagnosing patients suspected of ear disease necessitates air and bone conduction audiometry, typically conducted within a sound-treated environment to ensure accurate threshold measurements down to -10 dB HL. However, the challenge arises when utilizing Self Test Kits, as they often require testing in less-than-ideal environments, posing difficulties for bone conduction assessments, which are not easily self-administered. Addressing this challenge is crucial to effectively distinguish patients requiring conventional clinic-based services, such as those with suspected ear disease or conductive hearing loss, from those with sensorineural hearing loss who may benefit from hearing aids. Fortunately, recent advancements offer alternative audiological testing methods to assess the risk of ear disease. In response to this need, we have developed hearRisk, a revolutionary solution designed to detect conductive hearing loss risk with an impressive 95% accuracy rate. This proprietary tool effectively identifies the 3% of patients who may not be suitable candidates for hearing aids, directing them to seek further evaluation at a clinic if necessary. While the hearX Self Test Kit does not include bone conduction audiometry, it does offer the invaluable hearRisk product, which serves as a reliable screening tool. Furthermore, our comprehensive approach includes FDA-recommended questions to detect potential ear disease and the option to utilize the CEDRA questionnaire to identify specific conditions. By leveraging these innovative solutions, healthcare providers can confidently navigate the complexities of diagnosing ear-related conditions, ensuring optimal patient care and treatment pathways.

The hearTest pure tone audiometry test stands as a clinically validated assessment, with peer-reviewed studies showcasing its efficacy. Research findings, such as those outlined in the article "Smartphone threshold audiometry in underserved primary health-care contexts," underscore the accuracy of air-conduction audiometry achievable both within and outside of a traditional sound booth setting.

Furthermore, studies such as "Accuracy and Reliability of Smartphone Self-Test Audiometry in Community Clinics in Low Income Settings: A Comparative Study" further corroborate the reliability of smartphone-based self-test audiometry. This research highlights the capability of such technologies to deliver precise air conduction hearing thresholds, with a sensitivity exceeding 90% for detecting hearing loss greater than 40 dB HL in individual ears.
For comprehensive insights into the research supporting hearX products, please visit our published research page at: https://www.hearxgroup.com/research-and-impact-reports.

With the purchase of the hearScope add-on, the hearX Self Test Kit expands its capabilities to include a digital video-otoscope, empowering patients to conduct examinations at home, during curb-side tests, or as part of counter-side testing scenarios. Users receive comprehensive guidance through detailed tutorials, facilitating the capture of tympanic membrane images to assess potential ear canal obstructions that could impede hearing aid fitting.
The utilization of the otoscope for in-home testing remains at the discretion of patients. In instances where patients encounter challenges in handling the otoscope due to dexterity issues, assistance can be provided by a partner, friend, family member, or caretaker. Notably, the otoscope is equipped with specula significantly shorter than those found in clinical settings, prioritizing patient comfort and enhancing the overall ease of use.

Firstly, the hearX Self Test Kit includes an optional pre test noise check to ensure the environmental noise is below the maximum permissible ambient noise level (MPANL) for the headphone type in use.
Secondly, the testing process utilizes noise monitoring during the test to temporarily pause and suggest a restart if necessary. If the surroundings become excessively noisy, users receive an alert via the app, prompting them to relocate to a quieter area for testing. Additional quality control measures monitor the response times and false response counts to indicate the test reliability. These comprehensive metrics are integrated with the test results to provide the Audiologist with valuable test insights.

As long as the smart device is connected to a stable internet connection, the test results will be transmitted instantly via a secure cloud service and will be accessible on both the mHealth Studio Cloud and on the mHeath Studio app. This ensures that test results are available asynchronously, providing access to all relevant patient test data. All data seamlessly integrates with the mHealth Studio Cloud data management software.

While our solution is built on commercially available off-the-shelf hardware, the smart device used for hearX STK is standardized to comply with specific industry standards. This standardization ensures that the device generating the pure tones for screening can be accurately calibrated. This calibration is essential to ensure that the decibel levels are precise and reliable. hearX cannot guarantee accurate or reliable sound levels on personal smart devices, as they have not been standardized and calibrated and therefore hearX STK cannot be installed on personal smart devices. Only devices procured directly from hearX, for this purpose, can be used.

The hearX Self Test Kit is versatile and can be utilized in various settings, including curb-side testing within drive-through facilities and home testing environments. It is essential to stay informed about and compliant with all regulations applicable to your practice, particularly those related to the remote fitting of hearing aid devices. Regulatory requirements in this field are continually evolving, especially concerning remote medical evaluations and the practice of remote care.
hearX does not provide any warranty or assurance regarding the purchaser's right or authorization to use the product for its intended purpose within a specific territory. It is the purchaser's responsibility to comply with all relevant territorial regulations, including both state and federal guidelines.

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 starts and tutorials are added at key points to ensure that the patient can easily complete the hearing assessments.

As long as the smart device is connected to a stable internet connection, the test results will be transmitted instantly via a secure cloud service and will be accessible on the mHealth Studio Cloud.

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. The reference number is then an optional field and can be skipped. Please refer to the training manual for instructions on how to disable the reference number.

A patient cannot access test results pertaining to other individuals. Upon completing the assessments, each patient can only view their own simplified results, accompanied by a brief explanation.

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.

Yes, the hearX Self Test Kit comes with a 1-year out-of-box warranty. If a device fails within the first year, then the supplier warranty applies. Please note that the time for the replacement of a smart device may take up to 3 months.

Yes, all headphones must be calibrated annually. The calibration status is displayed on the tablet, and a warning message will appear as the calibration expiry date approaches. Once the calibration expires, the headphones must be returned to the service center for recalibration. After the re-calibrated headphones are returned, they should be re-linked to the tablet and will be valid for another 12-month period.

All headphones should be calibrated at a hearX approved calibration facility. Please email hearX at support@hearxgroup.com or contact the office during business hours: Monday to Friday, 9am to 4pm SAST for RSA at +27 (0) 12 030-0268, or 7am to 4pm EST for the US at +1 (415) 212-5500

Please feel free to send any support issues to support@hearxgroup.com. Our friendly support team will review your issue and get back to you within 24 hours. If your issue is urgent, please contact our offices during business hours: Monday to Friday, 9am to 4pm SAST for RSA at +27 (0) 12 030-0268, or 7am to 4pm EST for the US at +1 (415) 212-5500