March 11, 2008
In 2006, HearingMed hosted a successful pilot study to demonstrate the use of “cold” medical laser therapy in improving unaided word recognition in hearing impaired patients. As a result of this study, HearingMed is providing Institutional Review Board (IRB) approved test sites for an expanded, double-blind, placebo controlled clinical trial. The trial data to be presented at the AudiologyNOW! Conference in April, “Effects of Low Level Laser Light Therapy on Word Recognition,” is part of an on-going clinical trial.
The laser device used in the study is the Erchonia Hearing Laser. While this device and its application to word recognition in this study is not currently approved by the FDA, several Erchonia Medical lasers have received FDA clearance for various therapeutic indications.
Current study plans call for the collection of sufficient data to support a submission to the FDA for application of the Erchonia Hearing Laser to improve word recognition. HearingMed is collaborating with the GN Resound Group, Glenview, IL, to explore the basic and applied implications of the project.