Sound Pharmaceuticals, a pioneer in the development of novel drug treatments for inner ear disease, announced today that Jonathan Kil, MD, Co-Founder and Chief Medical Officer, is a co-author on two publications from the Department of Defense’s Hearing Center of Excellence (HCE). The HCE is focused on the prevention, diagnosis, mitigation, treatment, and rehabilitation of hearing loss. HCE is congressionally directed to partner with the Department of Veterans Affairs (VA), and other organizations that support the study of auditory injury. The papers are part of a series of new guidance documents from the HCE published in the September issue of Otology & Neurotology, a leading otolaryngology journal.
Dr. Kil, along with leading academic scientists and clinicians, summarized the most significant sensorineural events that contribute to noise induced hearing loss. More specifically they defined a temporary hearing loss as loss of hearing sensitivity within two weeks of a noise exposure, and the risk for developing a permanent hearing loss between two and four weeks after a noise exposure. Permanent hearing loss due to noise is thought to occur after four weeks or 30 days from the last exposure, and can be accompanied by tinnitus, the perception of sound in the absence of sound. In addition, the working group defined the use of pure tone audiometry in clinical trials and the occurrence of a significant hearing loss or threshold shift (STS) as a 10 dB loss of hearing. This definition of STS is considered clinically relevant and is determined by repeat pure tone audiometry overtime. These new guidance will help establish the standards necessary for future pivotal clinical trials that will enable the review and approval of the first neurotologic drug. Currently, there are no FDA approved drugs for the prevention or treatment of any sensorineural hearing loss indication or tinnitus.
Hearing loss and tinnitus are two of the most significant causes of disability compensation in the VA which exceeds $3 billion annually. This cost of auditory injury has more than doubled over the last 10 years, and will continue to grow as veterans age.
Links to Publications:
Introduction to the Pharmaceutical Interventions for Hearing Loss Clinical Research Guidance Papers
Hammill, Tanisha L.; Packer, Mark
Guidelines for Auditory Threshold Measurement for Significant Threshold Shift
Campbell, Kathleen; Hammill, Tanisha; Hoffer, Michael; Kil, Jonathan; Le Prell, Colleen
Temporary and Permanent Noise-induced Threshold Shifts: A Review of Basic and Clinical Observations
Ryan, Allen F.; Kujawa, Sharon G.; Hammill, Tanisha; Le Prell, Colleen; Kil, Jonathan