Medical device approved for Hearing Loss

Background

A Hearing Device sponsor needed Food & Drug Administration (FDA) approval to get their device on the US market. Keyrus Life Science had done a pilot study with the sponsor in conjunction with a CRO in France. The sponsor was happy with the work being done and asked KLS to continue in partnership.

Challenge

For the sponsor device study, only one study needed to be done for regulatory approval. That study was done in Canada. The device was approved in Canada. The challenge for their planned phase IV in the USA became: would data from Canada be enough for approval in USA? We helped them in supporting FDA submission, Sponsor's FDA Approval Process and improving site relationships based on sponsor's issues in past studies

Approach

Keyrus Life Science randomized all patients, gathered quality data, and prepared documents for FDA submission.

Key results

Strong Regulatory Documentation

Device approved in United States

Strong partnership developed between Keyrus Life Science and the sponsor

Benefits

Having learned from the pilot study, the sponsor believed the experience Keyrus Life Science had in Regulatory Affairs would be of benefit to their study.