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Oticon Medical Selects SMART-TRIAL Software to Accelerate Hearing Implant Clinical Trials

First application is ongoing data management of the Ponto sound processor product

Medical software innovator MEDEI ApS today announces that Oticon Medical has selected its SMART-TRIAL software to collect and manage clinical trial data of all current and future hearing implant products.  The software will enable Oticon to enter the digital-driven clinical trials ecosystem era and reduce the time to market for implant innovations.

“As one of the world’s leading hearing implant companies undertaking clinical trials of many pipeline products at numerous sites, we need to improve the quality of clinical data collection,” says Sofia Jonhede, Director of Clinical Affairs for Oticon Medical. “SMART-TRIAL will enable our many clinical specialists to better collaborate, interact and speed the collection of clinical evidence.”

“Clearly, we are delighted that Oticon Medical has chosen our SMART-TRIAL solution for implant clinical data management,” adds Jón Ingi Bergsteinsson, MEDEI’s vice-president of global business development. “This is another ringing endorsement of how our software can be used by medical device manufacturers to work smarter and shape medical innovation.”

Oticon Medical is a global company in implantable hearing solutions and is dedicated to bringing sound to people at every stage of their lives. The company is made up of highly experienced people who are committed to putting patient needs first.

The first use of SMART-TRIAL at Oticon Medical is for ongoing data management of the Ponto sound processor product which enables those with partial hearing loss to understand what others are saying by protecting speech clarity and fading out background noise.

SMART-TRIAL is leading the medical device industry into the digital-driven ecosystem era to improve the time to market for medical innovations. Today, the platform is used in clinical trials by medical device manufacturers in global markets as well as by clinical research institutions.

SMART-TRIAL enables medical device manufacturers to show EU regulators that their devices comply with the EU’s Medical Device Regulation (MDR), a norm which becomes mandatory in 2020 for OEMs to sell their products into the region.