Option 1

Option 2

Option 3

Submit complete multicenter Phase III Definitive Clinical Trial application.  A detailed Manual of Procedures (MOP) must be submitted as an Appendix to the application.

Reviewed by NIDCD Peer Review Group

Reviewed by National Deafness and Other Communication Disorders Advisory Council

Submit a NIDCD Clinical Trial Planning Grant

Submit complete multicenter Phase III Definitive Clinical Trial application.  A detailed Manual of Procedures (MOP) must be submitted as an Appendix to the application.

Reviewed by NIDCD Peer Review Group

Reviewed by National Deafness and Other Communication Disorders Advisory Council

Submit Preliminary (Phase I and/or Phase II) Clinical Trial Application

Reviewed by NIDCD Peer Review Group

Follow Path of Option 1

Follow Path of Option 2