Do you need to document that your hearing solution is compliant with standards and market requirements?

Get help to test, certify and document any hearing solution to ensure market access.

Any hearing solution that intends to alleviate hearing loss must prove it can do what it claims. It must adhere to strict hearing product standards and documentation requirements that may vary from market to market. This includes:

  • traditional hearing aids
  • Over-the-Counter (OTC) hearing aids
  • earbuds
  • lifestyle consumer wearable

Solid market access strategy for your hearing solution saves time and money

You can save  time and money as you go to market by partnering with us and using our test and certification expertise. The partnership typically involves a mix of physical tests and documentation reviews, ensuring compliance with processes and requirements.

We guide you through the documentation and test process every step of the way. We can contribute to shaping the market access strategy by offering pre-testing during the design phase that can map out the scope of requirements and documentation levels.

Test, documentation, and labelling of hearing solutions and hearing aids

Services at our state-of-the-art facilities include technical audiology testing for hearing solutions and acoustical hearing aid testing using sinusoidal and speech-like signals testing. Testing electrical safety, EMC, radio parameters (including Bluetooth), risk management, usability, software, mechanical strength, environmental stress, and documentation and labelling all contribute to helping you launch a new hearing product or enter a new market with an existing product.

Testing capabilities for hearing aids and hearing solutions

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Reliability tests

Tensile, drop, mechanical shock and vibration, thermal shock (high/low temperatures and humidity), pressure, biocompatibility standards (ISO 10993), toxicological harmful chemicals, harmful substances such as phthalates and latex, wear testing, artificial earwax testing, sweat testing, battery compartment testing, dust testing (IP IEC 60529), and battery life testing.

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Sound quality tests

Using SenseLab, a world-leading, widely recognised evaluation system with a trained listening panel and facilities meeting the highest standards.

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Hearing aid battery testing

Primary and secondary batteries: IEC 60086-1, -2; EHIMA recommendations for Zinc-Air Hearing Aid Batteries. Adjacent management systems and quality management systems for medical device manufacturers, including requirements for documenta-tion, traceability, risk management, process and product validation, helping to comply with industry and regulatory requirements.

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Certification of services and compliance documentation

Medical Device Regulatory (MDR); FDA; EC; IECEE CB Scheme via FORCE Certification. To guide you through the extensive regulatory framework for market access, we have a specialised Approval Management Team ready to assist with coverage, definition, composition of approval documentation and project management to ensure that the enabling markings and declarations of conformity, as well as all other parts of the documentation basis, are in place.


Get access to a full package of testing to relevant hearing product standards

Based in Denmark, home to some of the world's leading hearing aid companies, we have contributed to developing standards for hearing solutions for decades. We are proud to be among a select group of test houses with the facilities, expertise and accreditations to offer a broad spectrum of services tailored to support hearing product manufacturers in gaining global market access.

Which hearing product standards do we test and certify according to?