Clinical patient care

Hearing assessments for clinical trials

  • Streamline your processes
  • Get accurate results
  • Safeguard participant hearing health

Make participant hearing safety part of your clinical trials

We understand the important role participant safety plays in clinical trials. These trials drive medical innovation, and breakthroughs that can improve care and patient outcomes.

Some therapeutics, however, can cause hearing loss. This is known as ototoxicity.

Without proper monitoring, this can compromise both participant safety and the integrity of your study’s results. That’s why we offer solutions developed to integrate hearing safety into your trial processes, helping you to ensure comprehensive care and accurate outcomes.

The hearX® process for clinical trial sponsors

hearX aims to simplify hearing assessments in clinical trials, offering advanced, portable technology, customizable processes, and exceptional service tailored to your needs.

With a proven track record across diverse therapeutic areas, we can assist you with your participants’ safety, data accuracy and integrity from setup to study completion.

Our products adhere to various industry guidelines and standards to support quality outcomes in your trial.

Download our process guideView our clinical solutions

Our core offering

Partnering with hearX provides you with access to

Ototoxicity monitoring
Customizable solutions
Seamless integration with trial workflows
Expertise trusted by leading clinical trial sponsors

Browse our products

CE-certified digital audiometer

hearTest

CE-certified digital audiometer

hearTest combines capabilities of a traditional clinical audiometer with the convenience of mobile testing.

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NextGen app-based OAE device

hearOAE

NextGen app-based OAE device

hearOAE is our new Bluetooth®-compatible otoacoustic emissions (OAE) device that seamlessly integrates with designated hearX smartphones, tablets, and our cloud data management portal.

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To learn more about each feature,
go to our FAQs section below

Go to FAQs

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Frequently Asked Questions

What are ototoxic medications?
Certain medications can damage the inner ear and result in hearing loss, tinnitus, or balance disorders. This is known as ototoxicity.

According to the American Speech and Hearing Association (ASHA), there are over 200 ototoxic medications (which includes prescription and over-the-counter options) on the market today. These include medications used to treat serious infections, cancer and heart disease.
What is Extended High Frequency (EHF) testing?
Extended High-Frequency (EHF) audiometry is a hearing test that evaluates sensitivity in the higher frequency range of human hearing, typically from 10,000 Hz to 16,000 Hz, beyond the standard testing range of 250–8,000 Hz used in conventional audiometry.
What’s the difference between EHF testing and standard hearing testing?
Standard hearing tests primarily assess frequencies essential for human speech and communication. EHF testing, however, can detect damage to the sensitive ear hair cells earlier than standard tests, even before the patient notices symptoms.
How do I know which product is the best fit for our clinical trial?
For a more precise guideline, go to our Product Match Guide
What are the critical use conditions for hearTest?
- Ambient noise levels need to be as per **ISO 8253-1**
- The testing environment must be free from distractions
- The patient must be able to understand communication from the tester.
Can hearTest protocols be changed?
hearTest allows the sponsor to choose their own protocols with a frequency test range of 125 Hz - 16000 Hz (EHF) with the DD450 headphones. Please note that protocols are set per study.
With which standards does hearTest comply?
For a full list of standards, please visit our hearTest product page.
What does hearOAE do?
The hearOAE is used in an audiological test battery. It documents cochlear outer hair cell function using Transient Evoked Otoacoustic emissions (TEOAEs) and/or Distortion Product Otoacoustic Emissions (DPOAEs). Please note: Patients need to remain still and quiet during the test.
Who are the intended users of hearOAE?
The intended user population consists of trained personnel, such as audiologists, ENT surgeons, medical doctors, hearing healthcare professionals or other personnel with a similar level of education.
Please note: This instrument should not be used by personnel who do not have the necessary knowledge and training to understand its intended use and how the results should be interpreted.
What are hearOAE’s critical use conditions?
  • Tests need to be conducted by trained personnel, such as audiologists, ENT surgeons, medical doctors, hearing healthcare professionals or other personnel with a similar level of education.
  • This instrument should not be used by personnel who do not have the necessary knowledge and training to understand its intended use and how the results should be interpreted.
  • The ear canal needs to be visually examined, to prepare the patient for the assessment.
  • The patient needs to remain as quiet and still as possible when the assessment is performed.
  • The testing environment needs to be free from distractions and ambient noise.

Our Locations

USA

hearX USA
501 Boylston Street,
Floor 10
Boston, MA 02116

South Africa

Ground Floor, Building 2,
Ashlea Gardens Office Park,
180 Garsfontein Road,
Ashlea Gardens,Pretoria,
0081, South Africa

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