The Defense Health Agency's Hearing Center of Excellence collaborated in a first-of-its-kind effort to aid in the development of future drug therapies and devices for patients with hearing loss. During the meeting authorized by the Food and Drug Administration, patients with hearing loss shared their testimonies.
The Hearing Loss Association of America (HLAA) hosted the externally led, patient-focused, drug development meeting for people living with sensorineural (inner ear damage) hearing loss May 25, with key FDA reviewers in attendance. The FDA establishes these types of meetings to help inform its decisions and supervision during drug development and review of marketing applications.
"This was an important opportunity for patients to tell the FDA about their symptoms, assessment of current treatments, experiences, and challenges they face living with hearing loss as a way to personally address their needs and conditions," said the HCE's division chief, Dr. Carlos Esquivel. "We were honored to collaborate as a patient organization with a dedicated interest in improving care and medications for those with hearing loss."
During the meeting, Dr. Gavin Imperato, with the FDA's Office of Tissues and Advanced Therapies, expressed enthusiasm at the opportunity to hear from patients as the FDA considers specific therapies for people with hearing loss.
The event included two panels of people with hearing loss and a group of patients, caregivers, and their families joining remotely, who shared their most burdensome symptoms, current treatments, and what they would like to see in future therapies.
According to the HLAA, the report Voice of the Patient will be published in the fall based on information from the meeting and comments from patients submitted to the organization through June 25.
The HCE's collaboration in the virtual meeting is a continuation of the center's ongoing engagement with the HLAA on several initiatives, dating back to 2014, according to Esquivel.
In other related efforts, HCE is leading the Pharmaceutical Interventions for Hearing Loss Working Group, which is examining drug development initiatives for service member and veteran hearing loss. The center also provides subject matter expert support to the Department of Defense's acquisition of the Pharmaceutical Intervention for Noise-induced Hearing Loss initiative.