Document that your hearing solution is compliant with standards and market requirements

70% of hearing solution approval processes need to start over due to inadequate documentation

The regulatory process for hearing solutions like traditional and OTC hearing aids, earbuds and lifestyle wearables is complex and full of pitfalls. Small to medium-sized manufacturers often face significant challenges, leading to incomplete documentation, inadequate testing and unmet market-specific requirements. Consequently, 70% of products must restart the approval process, incurring additional time and financial costs and delaying product launches. Compliance with new FDA standards adds further difficulty for OTC products, requiring a meticulous and hands-on testing approach.

We approve about 80% of all hearing aid devices on the market

We specialise in testing and documenting the standard compliance of hearing aid devices, covering technical audiology, acoustics, electromagnetic compatibility (EMC), reliability and electrical safety. Annually, we issue over 700 detailed reports confirming these devices' quality and durability for global manufacturers. Our comprehensive evaluation process is pivotal in approving approximately 80% of all hearing aid devices launched on the market. Beyond test results, we provide invaluable guidance tailored to your product's regulatory journey, leveraging our expertise to expedite market entry while maintaining uncompromising quality.

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.

Sound quality tests

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

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.

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.