PIHL Research Guidance
The Pharmaceutical Interventions for Hearing Loss (PIHL) working group was chartered in 2012 for the purpose of reviewing and maintaining state-of-the-science knowledge that supports translational therapies for the prevention and rescue of noise-induced hearing loss. Foundational knowledge can be used to spotlight minimal functional performance requirements of potential agents and, importantly, to identify the evidence-based laboratory, animal, exposure, and clinical assessment methodologies that represent best practices. It can also be used to promote comparability across trials investigating new drug development.
The guidance offered below is the culmination of two years of working group discussion, literature review, and open dialogue during two state–of-the-science symposia involving expert investigators. Discussions focused on analyzing issues most relevant to participation in investigational new drug (IND) development and translation of science for the prevention and/or rescue of hearing loss. It represents the outcome of subject matter review, debate, and advisory consensus to bridge literature gaps and recommend appropriate standards and technologies for future PIHL studies.
Hearing injuries due to noise have claimed, and continue to claim many thousands of military and civilian casualties. Noise-induced hearing loss limits communication, opportunity, and overall quality of life. Advances in the development of pharmaceutical intervention can play a critical role in preventing noise-induced hearing loss. Through PIHL, the HCE works to guide and facilitate research and its translation to benefit military members.
Downloadable PDF links:
- Biomarkers of Oxidative Damage and Inflammation
- Guidelines for Adult Auditory Threshold Measurement for Significant Noise Induced Threshold Shift
- Measurement of Tinnitus
- Non-Cochlear Effects of Noise
- Statistical Considerations
- Supra-Threshold Testing Using Speech-in-Noise and Auditory Evoked Potentials
- Temporary and Permanent Noise-Induced Threshold Shifts
- The Genetic and Epigenetic Basis of Noise
- Use of Otoacoustic Emissions to Assess the Efficacy of a Pharmaceutical Otoprotective Agent