hearTest - CE-certified digital audiometer

In hearTest, the user can create their own protocols with a frequency test range: 125 Hz - 8000 Hz with the HD280 headphones and a frequency test range: 125 Hz - 16000 Hz (Extended High Frequency - EHF) with the HD300 headphones. Please refer to the hearX Training Platform on how to create your own custom protocol.

While our solution is built on commercially available off-the-shelf hardware, the smart device used for hearTest 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 hearScreen cannot be installed on personal smart devices.

hearTest complies with the following international standards:
- **IEC 60645-1**: Electroacoustics - Audiometric equipment - Part 1: Equipment for pure-tone and speech audiometry
- **ANSI/ASA S3.6**: Specification for Audiometers (type 4 audiometer)
- **ISO 8253-1**: Acoustics, Audiometric test methods Part 1: Pure-tone air and bone conduction audiometry
- **ISO 389 series**: Acoustics, Reference zero for the calibration of audiometric equipment - Part 2: Reference equivalent threshold sound pressure levels for pure tones and insert earphones
- **BS EN ISO 13485**: Medical devices - Quality management systems - Requirements for regulatory purposes
- **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
- **BS EN ISO 14971**: Medical devices: Application of risk management to medical devices
- **EN 62366-1**: Medical Devices - Part 1: Application of usability engineering to medical devices
- **IEC 62304**: Medical device software - Software life cycle processes
- **EN ISO 14155**: Clinical investigation of medical devices for human subjects - Good clinical practice
- **ISO 20417**: Information supplied by the manufacturer with medical devices
- **EN ISO10993-1**: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Yes, hearTest does allow 0 dB testing on the Sennheiser HD 280 Pro hardware set and can allow testing down to -10 dB with the RadioEar DD450 and DAC hardware set.

hearTest is a certified type 4 audiometer and is suitable for conducting screenings outside of an audio booth. It remains the responsibility of the user to ensure the compliance of the test environment according to the relevant local standards. hearTest Occ Health hardware set (insert earphones covered by earmuffs) exceeds ambient noise attenuation required for screening audiometry (e.g. ISO/SANS 8253-1). This level of attenuation is comparable to that of a single-wall soundproof booth. Download our white paper study here.