Disclaimers & Patient Safety Information
Please read below disclaimer carefully.
A. Agreement between user and Oticon Medical
- "Oticon Medical" means Oticon Medical AB, a limited liability company, registered in Askim under registration No. 556741-3132 and having its registered address at Datavägen 37B, SE-436 32 Askim, Sweden or any corporation or other entity controlled by Oticon Medical AB or affiliated to Oticon Medical AB.
B. User information
- We may request, in order for you to use certain areas of this Website, that you register, create a user or member name, create a password, or otherwise log in with your email address or with a user or member name which you select. In the event that your use of or participation in any portion of this Website requires that you register, create a user or member name, create a password, or otherwise log in with your email address, you agree that:
You shall not (i) select or use a user or member name or email address of another person with the intent to impersonate that person; (ii) use, without authorization, a user or member name or email address which belongs to anyone other than you or which is subject to the rights of any person other than you; (iii) use a user or member name in violation of the intellectual property rights of any person; or (iv) use a user or member name that Oticon Medical, in its sole discretion, deems offensive; and
You shall take any and all actions necessary to maintain the privacy of your password.
C. Agreement not transferable
D. Use of bulletin boards, chatrooms, and other communication forums
- You agree not to upload, post, or otherwise make available any material protected by copyright, trademark, or other proprietary right on this Website, without the express permission of the owner of the copyright, trademark, or other proprietary right. The burden of determining that any material is not protected by copyright, trademark or other proprietary right rests on you. You shall be solely liable for any damages resulting from any infringement of copyrights, trademarks, proprietary rights, or any other harm resulting from any uploading, posting, or submission.
- You agree not to upload files to this Website that contain viruses, corrupted files, or other similar software or programs that may damage the operation of another person's computers, software, websites, or network. You will be solely responsible for damages arising from any claims that files posted by you caused damage to the operation of another person's computer, software, websites, or network.
E. Disclaimer of warranties and limitation of liability
- Use at own risk. You agree that use of this website is at your own risk. Oticon Medical does not make any warranty as to the results that may be obtained from use of this website or as to the accuracy, reliability or contents of any information provided through this website.
- Warranty disclaimer. The contents of this website are provided by Oticon Medical as a service. This website does not contain all information that may be relevant to hearing loss issues in general or to your or any other individual's situation in particular. All contents provided on this website are only general information regarding hearing loss issues and are intended only to facilitate communication between you and your hearing care or other professional healthcare provider. Contents provided on this website are not intended as and cannot provide either a diagnosis of a specific problem or condition or a specific recommendation of the appropriate treatment. Contents provided on this website should not be used as a substitute for seeking professional hearing care or other care. All specific questions you may have about your hearing loss condition, treatment, care or diagnosis should be presented to your own professional hearing care or other professional healthcare provider. Oticon Medical is not liable for any personal injury, including death, caused by your reliance on or your use or misuse of any information presented or contained on this website.
Except if expressed and unambiguously stated otherwise, Oticon Medical does not in any way endorse, operate, control or assume responsibility for any information regarding any services offered or provided by any third party, which or who may be listed on or linked to this website including any hearing care center or service provider, which or who may be listed on or linked to this website.
This website may include contents provided by third parties and users. For any and all such contents, Oticon Medical is a distributor and not a publisher. Oticon Medical has no more editorial control over such contents than does a public library or newsstand. Any opinions, advice, statements, services, offers or other information expressed or made available by third parties (including hearing care centers and other professional hearing care service providers and other merchants and licensors) are those of the respective authors or distributors of such contents and not of Oticon Medical. Oticon Medical makes no warranty as to the completeness, accuracy, currency, or reliability of information published by Oticon Medical on this website.
When using this website information will be transmitted over a medium, which is beyond Oticon Medical's control and jurisdiction. Accordingly, Oticon Medical assumes no liability for or relating to the delay, failure, interruption or corruption of any data or other information transmitted in connection with the use of this website. Oticon Medical expressly disclaims any warranty that the services or contents provided by or on this website will be uninterrupted as to the results obtained from use of the services or contents. The services and contents are distributed on an "as is, as available" basis, and Oticon Medical makes no warranties of any kind, either express or implied, including without limitation warranties of title or non-infringement or implied warranties of merchantability or fitness for a particular purpose.
By using this website you acknowledge that your use of this website is at your own risk, that you assume full responsibility for all risk associated with your use of this website, including without limitation responsibility for all costs associated with all necessary servicing or repairs of any equipment you use in connection with your use of this website.
- Linked websites. Oticon Medical does not endorse, warrant or guarantee any product or service offered by a third party through this website and will not be a party to or in any way monitor any transaction between you and any third-party provider or products or services.
G. Links to third-party sites
- This Website may contain links to other websites operated by parties other than Oticon Medical. Such links are provided for your reference only. Oticon Medical is not responsible for the availability of these external sites nor is it responsible for any of the content, advertising, products, or other materials on such external sites. Any concerns regarding any external link should be directed to its respective website operator.
- Oticon Medical respects the privacy of visitors to this Website. Oticon Medical will only collect personally identifiable data, such as your name, address, telephone number, or e-mail address, when it is voluntarily submitted to Oticon Medical at this Website. Oticon Medical may use this information to comply with your request for information or as otherwise disclosed to you at the specific location at which you submit your information. From time to time, Oticon Medical may consider the information to better understand your needs and how Oticon Medical can improve the quality of this Website and Oticon Medical may use the information to contact you.
- This Website also uses information to track the total number of visitors to this Website, the total number of visitors to each page of this Website, and the domain names and country of origin of our visitors or their internet service providers. Normally no personally identifiable information is available in this process.
- This Website is not intended or designed to attract children under the age of 13. Oticon Medical does not collect personally identifiable data from any person Oticon Medical knows to be under the age of 13.
- The privacy policies and procedures of Oticon Medical described herein do not apply to third-party sites. Oticon Medical suggest that you contact those third-party sites directly for information on their data collection and distribution policies.
I. Copyright and limitations on use
- The Content made available through this Website by Oticon Medical is the property of Oticon Medical and/or Oticon Medicals licensors and is protected by copyright and other applicable laws. Oticon Medical reserves all rights. Information received through this Website may be displayed, reformatted, and printed for your personal, non-commercial use only if you include the following copyright notice: "Copyright 2010 Oticon Medical AB. All rights reserved." and any and all other copyright and proprietary rights notices which were contained in the Content. You agree not to reproduce, retransmit, distribute, disseminate, sell, publish, broadcast, or circulate the information received through this Website to anyone, including but not limited to others in the same company or organization, without the express prior written consent of Oticon Medical.
- You expressly grant to Oticon Medical the royalty free, perpetual, irrevocable, non-exclusive, world-wide license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform, display and sublicense any message posted in, on, or through this Website (in whole or in part) worldwide and/or to incorporate it in other works in any form, media, or technology now known or later developed.
- "Oticon Medical" is a trademark of Oticon Medical A/S. All rights reserved. All other trademarks appearing on this Website are the property of their respective owners, including, in some instances, Oticon Medical. Reproduction, in whole or in part, is prohibited without express prior written permission.
- You agree that any link from a website that you own, control, or author in part or in full, to this Website shall be exclusively to www.oticonmedical.com and to no other web page within this Website. You agree that you shall make no link from a website that you own, control, or author in part or in full, if that website contains any material that violates or infringes in any way upon the rights of others, that is unlawful, threatening, abusive, defamatory, invasive of privacy or publicity rights, vulgar, obscene, profane, indecent, reflects negatively on Oticon Medical, or is otherwise objectionable, gives rise to civil liability, or otherwise violates any law, or that encourages conduct that would constitute a criminal offence.
L. Governing law
If you do not wish to download cookies onto your computer, you can block them through your browser's tool menu. However, if you do choose to block cookies, Oticon Medical cannot guarantee the correct functioning of its websites. You are always welcome to contact us for further information, either by e-mail to email@example.com or by telephone on +46 31 748 61 00
N. Reservation of Rights
- Any rights not expressly granted herein are reserved.
ANNUAL DECLARATION FOR PURPOSES OF CALIFORNIA HEALTH & SAFETY
CODE, §§ 119400-119402
On September 29, 2004, California Governor Arnold Schwarzenegger signed into effect California Health and Safety Code §§119400-402 requiring medical device companies including Oticon Medical, to adopt a compliance program (CP) to address misconduct relating to their interactions with healthcare professionals (HCPs). The CP must be in accordance with both the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals and with the "Compliance Program Guidance for Pharmaceutical Manufacturers," published by the Office of Inspector General (OIG), U.S. Department of Health and Human Services.
The statute requires each medical device company to:
- Establish in its CP a specific annual dollar limit on gifts, promotional materials, or items or activities that the medical device company may give or otherwise provide to a health care professional;
- Make an annual written declaration that it is in compliance with its CP and the new law;
- Make its annual declaration of compliance available to the public on its website;
- Provide a toll-free number to obtain a copy of the CP and the annual written declaration and;
- As changes are made to either the OIG Guidance or the PhRMA Code, the company's CP must be updated with corresponding modifications within six months.
Oticon Medical’s Declaration of Compliance in accordance with California Health and Safety Code §§119400-402 can be found listed below.
Oticon Medical’s Declaration of Compliance
January 1, 2018 - December 31, 2018
To the best of our knowledge, as of January 1, 2018 Oticon Medical, LLC and its employees are in compliance with its Compliance Program and the requirements of California Health and Safety Code statue as of April 1, 2018.
For purposes of complying with the Statute, Oticon Medical, LLC has established a maximum annual aggregate limit of $2,000 dollars for gifts, promotional materials, not related to patient education, and related activities provided to California HCPs.
However, this annual spending limit does not include the value of 1) product samples given to a HCP intended for free distribution to patients; 2) payments made for bone fide consulting services provided by a health care professional as long as it is provided at fair market value; 3) expenses incurred as part of the bone fide consulting services.
A copy of the company’s Code of Conduct can be provided by calling 888-277-8014. Please state that you are requesting a printed copy of Oticon Medical’s Code of Conduct. Oticon Medical will also provide upon request a copy of its Annual Declaration.
Massachusetts and Vermont
State physician transparency requirements: in addition to federal Open Payments reporting, some states also require annual data submission for covered recipients. Unlike the federal law, Massachusetts and Vermont also require reporting for all healthcare providers (not just physicians). These states have very strict regulations regarding what is allowed to be provided to healthcare providers in the form of a ToV, i.e., meals are usually not allowed. Oticon Medical complies with annual state reporting requirements that specifically include medical device manufacturers.
The Physician's Sunshine Act or now referred to as Open Payments was enacted into law by Congress to allow the public to see financial transactions between pharmaceutical, medical device manufacturers, and group purchasing organizations and certain health care providers. The law was implemented in section 6002 of the Affordable Care Act. The implementation and oversight of the Act is done by the Centers for Medicare and Medicaid Services (CMS). The legislation requires healthcare manufacturers to submit reports on an annual basis reportable financial transactions or Transfer of Values (ToV) provided to a covered recipient including physicians and teaching hospitals. The data is published on a public website by CMS every September for the previous year.
Oticon Medical is in full compliance with Open Payments reporting requirements and have made submitted annual reports since the first 2014. The website and data can be accessed by visiting www.cms.gov/open payments.
Risks and Contraindications
Cautions and contraindications for implantation
It is important to understand that there are patients who are not suited for or who are too young to receive an implant. Poor hygiene significantly increases the risk of adverse skin reactions. It is vital to be able to maintain proper hygiene around the abutment. Factors that affect this ability should be considered, as well as the possibilities of obtaining help to maintain sufficient hygiene if necessary. In children the responsibility falls on the parents or caregiver. Inability to maintain, or lack of help with maintaining sufficient hygiene around the abutment, is a contraindication for use. Patients with insufficient bone depth and bone quality have an increased risk of implant failure and potential need for revision surgery. Disease, history of irradiation or other factors that may affect the bone quality should always be considered in the individual surgical planning and assessment of the patient, before choosing to place an implant. Children must have sufficient bone volume and bone quality before implant placement. Studies indicate that the child should have a skull bone at least 2.5 mm thick. In the US, Canada and Singapore, the placement of a bone anchored implant is contraindicated in children below the age of five. Any skin status or condition resulting in an expected reduced healing capacity or increased risk of skin reactions should always be considered.
The patient shall be clearly informed about aftercare requirements, possible complications, and precautions for the surgical procedure when using the device. Potential intra-operative and post-operative complications include: Implant becomes stuck during insertion, implant continues to rotate when the flange is down, implant mobility, perforation of the sigmoid sinus and exposure of dura mater, damage to the skin graft, epidural hematoma, implant loss, inflammation and infection around the abutment, skin overgrowth, skin flap necrosis, intracranial complications, post-operative numbness-paresthesia, pain, bony overgrowth, keloids, bone infection, potentially causing osseonecrosis.