Oticon Medical’s Investigator Initiated Trials (IIT) Program
As a global leader in bone-anchored hearing solutions, research and scientific evidence play a central role for us at Oticon Medical. A key component of our research program is to support external research projects that advance scientific understanding in the field of bone-anchored hearing systems (BAHS) and can generate evidence to help improve clinical outcomes and promote patient wellbeing.
What do we support?
The objective of the study is determined by your own research interest. This can be any study that could contribute to enhancing the understanding of Oticon Medical products and their appropriate application. The study should align with the intended use of the product and have the potential to benefit patients, clinicians, or healthcare settings.
Easy application process
We have a continuous application process, so please submit your IIT proposal via email at any timepoint throughout the year. Please download the IIT proposal form and start your application process. All submitted proposals are reviewed by our IIT Forum, and we aim to give a timely answer if the proposal meets our research focus.
Type of funding
Our IIT support usually covers products or parts of the total study budget and focuses on expenses outside normal clinical practice. Since this type of project is sponsored and owned by the Investigator, the financial support excludes overhead.
Following the initiation of a study, funding is regulated by an agreement and given on a milestone basis as exemplified below:
- Favorable opinion/waiver from an institutional review board or ethics committee (25%)
- Signed and agreed funding agreement (25%)
- Full recruitment of patients or full collection of data (25%)
- Completion of a report or manuscript summarizing the results (25%)
What we need from you
To be considered for funding support, investigators must have the necessary infrastructure and capabilities in place to successfully carry out the proposed study. The following documents should be shared with Oticon Medical:
At initial IIT submission
- IIT proposal form
- Study synopsis
- Budget and funding request
- Current CV
Before funding
- Study protocol/plan, including design and method details
- Favorable opinion/waiver from EC and/or IRB
- Signed funding agreement
What happens after submission
We aim to make the process as open and easy as possible. Here is a summary of how we assess your proposal and when you can expect to hear from us.
- We confirm receipt of your study proposal and ask for more information if needed.
- We review your proposal, looking at: safety of the participating subjects, alignment with Oticon Medical research strategy, study design, statistics, probability that the study will lead to a meaningful publication in a peer reviewed journal, your qualifications, the study’s overall scientific merit, and whether your budget request is within fair market value.
- You will receive a written response with a rationale for our decision to either approve funding or reject your proposal.
- A funding agreement (IIT Agreement) is prepared and signed, describing the responsibilities of everyone involved.
- Regular study updates regarding study progress are expected. For example, Oticon Medical would be interested in hearing about:
- Recruitment updates
- Changes to timelines
- Issues or problems with treatment or protocol execution
- Expected result delivery
- Planned abstract submission and/or result communication
- Once your study is completed you are asked to submit a final study report. As part of Oticon Medical’s commitment to publishing research, you are also encouraged to publish the results in a peer-reviewed journal.
Downloads
Please submit proposals via email to: studyinfo@oticonmedical.com