Quality and Safety
At Oticon Medical, we never make compromises 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 13485:2016 and MDSAP 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 authorisations
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 in the US and Europe, for which we have applicable market authorisations and approvals issued by the relevant authorities.
Europe:
ISO Certificate – 13485:2016
EU MDR Class IIa and Class IIb Devices G10 10687 0003 Rev.01 OM AB
EU MDR Class I Devices in sterile condition G11 106872 0004 Rev. 00 OM AB
US:
FDA Clearance K213733 – Ponto 5 Superpower
FDA Clearance K211640 – Ponto 5 Mini
FDA Clearance K203807 – Ponto BAHS, MONO Surgery Kit
FDA Clearance K190540 – Ponto 4
FDA Clearance K161671 – Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
FDA Clearance K152067 – Ponto BAHS (Ponto BHX Implant, MIPS)
FDA Clearance K142678 – Ponto BAHS (14-mm abutment)
FDA Clearance K141616 – Sterilization Cassette
FDA Clearance K132735 – Ponto Plus and Ponto Plus Power
FDA Clearance K121228 – Ponto BAHS (system compatibility)
FDA Clearance K112053 – Ponto BAHS (Wide Ponto implant)
FDA Clearance K103594 – Ponto Pro Power
FDA Clearance K090996 – Ponto Pro
FDA Clearance K082108 – Ponto BAHS (original Ponto system clearance)
Other Countries
ISO 13485:2016 MDSAP
Oticon Medical products are also available in a number of other markets.
Please contact your local sales representative for further information