The Hearing Loss Association of America (HLAA) held an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) for people and families living with Sensorineural Hearing Loss (SNHL) on Tuesday, May 25, 2021. The meeting brought together people with SNHL and their families, representatives of the FDA, government agencies and the military, as well as representatives from state agencies. Meeting attendees included representatives from industry, academia, advocacy groups and nonprofit organizations; in total, seven supporters, 56 partners and one collaborator joined HLAA to support this meeting.

This EL-PFDD meeting was modeled after the work of the FDA’s Patient-Focused Drug Development (PFDD) initiative. PFDD is a systematic way of gathering patient perspectives on their condition and on available treatments. The information gathered at the meeting is presented in this “Voice of the Patient” report. The information in this report will be used to guide drug and technology development and inform the FDA’s benefit-risk evaluations when reviewing technologies and therapeutics to address hearing loss.

Sensorineural hearing loss (SNHL) results from damage to the hair cells or nerve fibers of the inner ear that convert sound into electrical impulses. Sensorineural hearing loss is not just a reduction of sound level and degradation of speech perception but includes a very complex and interfering combination of physical and psychosocial health concerns. There is no such thing as a “small” hearing loss and each hearing loss is unique with varying consequences and effects.

People with hearing loss described the impacts of hearing loss. Hearing loss is an invisible disability, is heavily stigmatized and leads to social isolation and a diminished quality of life. The strong link between hearing loss and dementia is a worry for people with hearing loss. Many expressed worries of being further isolated due to losing social connections and relationships, losing the ability to communicate and losing additional hearing. Those with hereditary hearing loss expressed worries for their children and grandchildren.

There is a continued unmet need for solutions to support people with hearing loss. People with SNHL use combinations of technologies, tools, medical treatments, accommodations and strategies to address their hearing loss. While most of these tools help to amplify sound and/or reduce symptoms of hearing loss, they are not able to replace hearing. Many commented on the high cost of hearing solutions, especially as many accommodations are required. While disease modifying or curative therapies for hearing loss are not yet available, people with hearing loss are hopeful that the future will provide better solutions that might restore or improve their hearing.

The hope is that the information obtained at this event will ultimately catalyze significant improvements for the health and quality of life for people living with SNHL.