NAL’s clinical trial process takes full advantage of the highly skilled multidisciplinary researchers at NAL. Our experienced and qualified clinical trials team (+15 years), scientific experts, professional audiologists and project management office are experts at measuring hearing device outcomes using both standardised and innovative tools, both in the lab and in the real world.
NAL is proud of our history of collaborating with globally recognised research institutes and industry partners to improve hearing health and transform the lives of people with hearing difficulties.
CLINICAL TRIAL SERVICES & CAPABILITIES
Clinical Trial Design & Execution
NAL provides medical device and diagnostic products trial expertise for the hearing industry in the following areas:
- Pilot and feasibility studies
- pivotal studies designed the collect safety and efficacy data
- post-market studies.
Our advanced assessment tools and emerging technologies such as access to real-time continuous clinical data enable the design of leading-edge clinical trials delivering credible data that shape hearing healthcare today and informs practice tomorrow.
Patient & Site Recruitment
NAL is a business entity of Hearing Australia, this integration with offers a unique extensive footprint (+600 clinics) to reduce the challenges of patient recruitment. This access to patients and short recruitment timelines help to improve trial success.
Summary of services:
- Study design
- Site & patient recruitment
- Advanced Audiological assessments
- Statistical analysis
- Clinical trial execution
- Medical writing
- Study monitoring
- Clinical trial operations & compliance (FDA, EU, TGA)
View a completed Clinical Trial to provide evidence for 510(k)
