Testimony of Dr. Jay G. Ronquillo
FDA Public Workshop on Hearing Aid Good Manufacturing Practices
Thank you very much for the opportunity to speak today. My name is Dr. Jay Ronquillo and I am speaking on behalf of the National Center for Health Research. I am a physician who trained at Massachusetts General Hospital, have two engineering degrees from Cornell, a Master of Public Health from Harvard, and a master’s in biomedical informatics from Harvard Medical School. These are the perspectives I bring with me today. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policy makers. We do not accept funding from the drug or medical device industry and I have no conflicts of interest.
Age-related hearing loss is an important condition affecting many patients. Hearing aids and related technologies are capable of improving the quality of life for many of these men and women. Increasing access and availability to these technologies will be critical, but their quality, safety, and effectiveness must also be a priority.
The PCAST report recommends creating a separate category for “basic” hearing aids. Over-the-counter sale of these hearing aids would likely increase the number of people who use hearing aids. However, there remain several unanswered questions regarding their quality and safety: Are current hearing aids sufficiently effective for this larger population? Do people with hearing aid problems know where and how to report major problems with either safety or effectiveness? Also, how do patients know which product will best meet their specific needs? Because the FDA currently regulates hearing aids as Class I or Class II devices, which require little (if any) data supporting their safety and effectiveness, the answers to these questions are not clear.
Similarly, over-the-counter sale of hearing aids would place the responsibility on patients to self-diagnose, self-treat, and self-monitor their specific type of hearing loss. For a patient population often affected by multiple conditions and taking multiple medications or treatments, this would place additional burden on patients without keeping manufacturers accountable for device quality and safety. Under this approach, there would likely also be more patients with non-age-related hearing loss that would go undiagnosed and untreated. And it would be even less likely that problems with these hearing devices would be reported or monitored. To avoid harming the public health, I urge you to recommend medical or clinical guidance.
In summary, we support the need to improve access to high quality hearing aids and other medical devices for the aging population. However, we are very concerned that there is a heavy focus on increasing the adoption of hearing aids that is not balanced by strong explicit attention to safety or to devices that work well for the individuals buying them. We recommend stronger evidence explaining and supporting the safety and effectiveness of devices that impact hearing.
Thank you again for the opportunity to speak today and for consideration of our views.