Accession Number:

AD1047647

Title:

Development of a Device for Objective Assessment of Tinnitus in Humans

Descriptive Note:

Technical Report,30 Sep 2016,29 Sep 2017

Corporate Author:

OtoScience Labs, LLC Jacksonville United States

Personal Author(s):

Report Date:

2017-10-01

Pagination or Media Count:

11.0

Abstract:

The primary device has undergone substantial engineeringbench testing and laboratory testing. Final refinements of the device are being completed in the last quarter of 2016. Secured IRB approvals for all study sites SIU, Portland VA, Madigan Army Medical Center. HRPO approvals obtained for all study sites. IRB Continuing Review CR and HRPO CR approvals also obtained for SIU and PVA. MAMC IRB CR and HRPO CR approvals are not due until June 2017 and September 2017. Optimizing devicetestprotocol based on feedback from our pilot work and consultants. Recruitment of subjects for testing at SIU is underway using a secondary device, which allows us to proceed with early protocol developmenttesting and for validating the primary device when it is ready.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE