The European Commission has rolled out new regulations designed to enhance the safety and quality standards for OTC hearing aids, focusing on critical areas such as wireless connectivity and consumer data protection. These changes are aimed at improving product reliability while addressing privacy concerns arising from the increasing digital integration of hearing aids.
For hearing aid distributors operating in the European market, these updated rules present a compliance challenge. Manufacturers will be required to conduct additional safety tests and provide more detailed product documentation, ensuring that all wireless features comply with data protection standards. Distributors will need to be prepared for possible delays in product availability as brands work to meet the new requirements.
At the same time, these changes open up significant opportunities for companies that can meet the rigorous standards. Being an early adopter of compliant products could offer distributors a competitive advantage, positioning them as trusted partners in a market that increasingly values both privacy and quality.
CADENZA over-the-counter hearing aids have CE 1639, ISO 13485, FDA certificates to meet local compliance. Hearing aid distributors are welcome to contact us and establish partnerships.