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Quality and Safety

At Oticon Medical we never compromise when it comes to the safety and efficiency of our products. Throughout the development process, safety and efficiency issues have been continuously addressed by engineers, clinical professionals and users. Thus, users and hearing care professionals can rest assured that our solutions meet current quality standards and essential requirements.

Quality assurance

Oticon Medical holds an ISO 13485:2003 Quality Management System Certificate for the design, manufacturing and marketing of our products. This enables us to provide products and related services that consistently meet or exceed regulatory requirements and customer needs.

Market authorizations

Our products comply with international regulations as well as the national regulations and laws pertaining to our business in every market in which we operate. Our primary markets are the US and Europe, for which we have applicable market authorizations and approvals issued by the relevant authorities.

Europe:

US:

Canada:

Oticon Medical products are also available in a number of other markets. Please contact your local sales representative for further information.

Ponto
No compromises on quality
Find out more
Find out more about how the Ponto System equates with other systems on the market in the FDA clearance document.
Empower more people

Empower more people with Ponto – the most powerful family of bone anchored sound processors.