Emerging Interventions for Age-Related Hearing Loss: Review of the CLARITY-1 Trial Through the Description of the Pharmaceutical Development Phases Purpose Hearing loss is one of the most common chronic disabilities in the aging population. A brief review of current knowledge about the nature of auditory dysfunction commonly associated with advancing age is provided. In addition to decreases in hearing sensitivity, age-related hearing loss (ARHL) is associated with poor ... Article
Article  |   October 01, 2018
Emerging Interventions for Age-Related Hearing Loss: Review of the CLARITY-1 Trial Through the Description of the Pharmaceutical Development Phases
Author Affiliations & Notes
  • Victoria A. Sanchez
    Auditory Rehabilitation & Clinical Trials Laboratory, Department of Otolaryngology–Head and Neck Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL
  • Disclosures
    Disclosures ×
  • Financial: Victoria A. Sanchez is a paid consultant for Autifony Therapeutics Ltd., Onotomy, Inc., and Boehringer Ingelheim International GmbH. Portions of the work discussed were supported by Autifony Therapeutics Ltd.
    Financial: Victoria A. Sanchez is a paid consultant for Autifony Therapeutics Ltd., Onotomy, Inc., and Boehringer Ingelheim International GmbH. Portions of the work discussed were supported by Autifony Therapeutics Ltd.×
  • Nonfinancial: Victoria A. Sanchez is an assistant Professor at the University of South Florida.
    Nonfinancial: Victoria A. Sanchez is an assistant Professor at the University of South Florida.×
Article Information
Development / Hearing Disorders / Part 2
Article   |   October 01, 2018
Emerging Interventions for Age-Related Hearing Loss: Review of the CLARITY-1 Trial Through the Description of the Pharmaceutical Development Phases
Perspectives of the ASHA Special Interest Groups, October 2018, Vol. 3, 51-60. doi:10.1044/persp3.SIG6.51
History: Received April 17, 2018 , Revised July 31, 2018 , Accepted August 21, 2018
Perspectives of the ASHA Special Interest Groups, October 2018, Vol. 3, 51-60. doi:10.1044/persp3.SIG6.51
History: Received April 17, 2018; Revised July 31, 2018; Accepted August 21, 2018

Purpose Hearing loss is one of the most common chronic disabilities in the aging population. A brief review of current knowledge about the nature of auditory dysfunction commonly associated with advancing age is provided. In addition to decreases in hearing sensitivity, age-related hearing loss (ARHL) is associated with poor temporal processing and poor binaural and spatial processing. These auditory deficits combine, leading to poor speech understanding, especially in challenging, noisy and reverberant environments. Recent research demonstrates that ARHL is correlated with greater risks of cognitive decline in older individuals. All of which bring increasing attention to the treatment options available to address the debilitating effects of ARHL. Although hearing aids, when utilized within a comprehensive intervention approach, are efficacious, older individuals with ARHL are known to continue to have difficulty understanding speech in challenging listening environments.

Conclusion The work described here was motivated by the possibility of innovative pharmaceutical approaches. For example, the first ever Food and Drug Administration Phase IIa clinical trial of a pharmaceutical approach to addressing ARHL, called CLARITY-1, was conducted. Highlights from CLARITY-1 including the rationale for the trial, the methodology used, and an overview of the results are presented through a phased regulation tutorial. The CLARITY-1 example serves to help audiologists in understanding the role of clinical trials in advancing interventions for ARHL as well as the challenges that exist for bringing new pharmacological treatments to market. Audiologists have an important role to play, both in educating their patients about the current state of pharmaceutical interventions and in partnering in the development of these interventions.

Acknowledgments
The author would like to thank members of the Auditory Rehabilitation & Clinical Trials Laboratory (ARCT Lab) and collaborators from Autifony Therapeutics Ltd. for their contributions to the work presented.
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