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:

• ISO Certificate – 13485:2003
• EC Certificate – MDD 93/42/EEC

US:

• FDA Clearance K121228 – Ponto Bone Anchored Hearing System
• FDA Clearance K112053 – Ponto Bone Anchored Hearing Implant System  
• FDA Clearance K103594 – Ponto Pro Power
• FDA Clearance K090996 – Ponto Pro Bone Anchored Sound Processor with Accessories
• FDA Clearance K082108 – OBC Bone Anchored Hearing Aid System

Canada:

• ISO certificate – 13485:2003 CMDCAS

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