Annual Report 2010/11 - Sonova

ISO 9001:2000 and 13485:2003 certification. In June 2010,
the Group's headquarters in Stäfa, Switzerland, was certified
to meet the ISO 14001:2004 environmental management
standard that ensures the environmental impact of products
and processes is minimized over the long run.
All of Sonova’s products are subject to the safety guidelines
set down in the European Medical Devices Directive (MDD).
Sonova’s hearing systems are compliant with EU Directive
MDD 93/42/EEC and ISO standards 9001:2008 and
13485:2003. As a result, Sonova is not allowed to use any
raw materials or substances classified as hazardous in its
production process; this directive also imposes restrictions
on the use of recycled or used components.
Supplementary technical certifications required by the EU
Radio & Telecommunications Terminal Equipment Directive
R&TTE 99/5/EU guarantee that end-users are protected
when using analog or digital wireless technology. Sonova
ensures biocompatibility in the use of the medical products
it manufactures to meet the EN ISO 10993-1:2003 standard.
In the US, hearing systems are classified as Category I
medical products that can be launched on the market
without pre-market and FDA approval with an exemption
in accordance with 510(k). The FDA recommends labeling
on packaging for wireless connection technologies that
indicates the potential for electromagnetic interference.
The FDA is currently assessing whether wireless solutions
should be tested for electromagnetic compatibility before
they are approved for the US market.
The Lyric hearing system was cleared for market introduction
by the US Food and Drug Administration (FDA) in
the 510(k) approval process (permit number: K081136) in
2008. As a medical device, Lyric is manufactured with
materials and processes that comply with the FDA Quality
System Regulation 21 CFR § 820. InSound Medical has
also been ISO 13485 certified since 2007, meaning it also
satisfies international requirements as a medical device
manufacturer. The systems for the US market have been manufactured
thus far in the United States. Starting June 2011,
Lyric is scheduled to be manufactured and dispatched primarily
from Sonova's Vietnamese Operation Center.
The cochlear implant and the respective accessories from the
Advanced Bionics brand are classified as active implantable
medical products which are regulated by the EU Directive
AIMDD 90/385/EEC and require approval in most
SUSTAINABILITY
markets. In the US, the HiRes 90K cochlear implant and
the corresponding accessories were approved via a premarket
approval supplement (PMA-S). The systems were
introduced to all other markets following this assessment.
The HiRes 90K cochlear implant was voluntarily recalled
in November 2010. This was a precautionary measure
based on two instances in which the product was removed
for safety reasons due to an extremely rare malfunction.
Advanced Bionics received CE certification from the European
notified body TÜV for changes to the manufacturing
process of the CI HiRes 90K and approval to resume distribution
of the implant in European markets in April 2011.
The implant will be reintroduced on the US market following
pending approval from the FDA.
ENVIRONMENT
SUSTAINABLE ENVIRONMENTAL MANAGEMENT
Sonova is actively engaged in the protection of the environment
and pursues the aim of preserving and promoting
the safety and cleanliness of working and living areas at
Group level. Sustainable business practices in the Group
are based on the efficient use of natural resources, preventive
measures to reduce environmental damage from
products and processes, minimizing waste, and the safe
and responsible disposal of residual waste.
The large majority of the materials Sonova uses to manufacture
its hearing systems are environmentally friendly.
Compared to other medical devices, the production of hearing
systems uses fewer materials and less energy – the same
applies to the environmental impact of processes and products.
Sonova also constantly endeavors to further reduce
its environmental impact.
Environmental standards implemented Group-wide include:
Ban on CFCs
Since 1992, Phonak has avoided using chlorofluorocarbons,
which damage the ozone layer, in its production processes
across the Group.
RoHS compliance
The EU directive RoHS 2002/95/EC (Restriction of Hazardous
Substances) was implemented Group-wide back in 2006
39