Hearing Health and Technology -- Workshop, Project No. P171200
Note to filing. These are personal comments and do not necessarily reflect the position of my employer. In August 2003, two Citizen's Petitions were submitted to the FDA. The petition from Dr. Killion advocated for the [FDA] Commissioner to create a new OTC (over-the-counter) hearing aid classification that grants over-the-counter sales, distribution and use status to one-size-fits-most hearing-aid-type devices that meet safety and efficacy requirements established by rule. The petition from Dr. Gudmundsen advocated for revised labeling changes in CFR, Title 21, Volume 8, specifically that the [FDA] Commissioner 1) revoke Section 801.421 it its entirety; 2) revoke all references to 801.421 in Section.420; and 3) replace the language in 801.421 (c) (3) in its entirety with the new language posted in this petition. In February 2004, the Department of Health and Human Services formally denied the Killion Petition (and presumably the accompanying Gudmundsen petition) because the "FDA continues to believe that the safe and effective use of hearing aids depends on the collateral measure of a physical examination to ensure that a hearing aid, rather than medical or surgical treatment, is the appropriate solution to a particular person's hearing impairment." Today, of prime importance to the 2004 FDA denial of the OTC Citizen's Petition is the 2016 Hearing Health Care for Adults report from the Committee on Accessible and Affordable Hearing Health Care for Adults under the National Academies of Science, Engineering and Medicine. Goal #3 in the HHCA report is "Remove FDA Regulation for Medical Evaluation or Waiver to Purchase a Hearing Aid. Recommendation 3: The Food and Drug Administration should remove the regulation that an adult seeking hearing aids be required to first have a medical evaluation or sign a waiver of that evaluation and should ensure customers receive information about the medical conditions that could cause hearing loss through continued inclusion of that information in hearing aid user instructional brochures." Justification for HHCA Goal #3 is on page 98 of the report. "This regulation was enacted in 1977 out of concern for the potential of hearing aids to be substituted for the medical or surgical treatment of hearing loss and possibly lead to further declines in patient health (Mann and Nandkumar, 2015). The committee explored this issue, obtained and evaluated data from the available literature and from the Department of Veterans Affairs (VA) and the Department of Defense (DoD), and concluded that the health risks were low, this regulation provides no clinically meaningful benefit, and the waiver presents a barrier to access with no substantial enhancement of patient safety." Subsequent to the HHCA report, the FDA changed policy regarding the requirement for medical clearance prior to the purchase of hearing aids. On 07 December 2016 the FDA issued a press release stating "The U.S. Food and Drug Administration today announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately." In summary, in 2003 Killion and Gudmundsen presented prescient Citizen's Petitions to address the increasing access and affordability crisis in hearing healthcare. The petitions were denied because is was (falsely) believed that physician clearance was necessary to insure public safety regarding amplification devices. The FDA has now reversed their position on the requirement for physician examination, which was used to deny the 2003 Petitions. As such, I recommend for OTC hearing aids and that the beginning point of discussion for technical aspects and product labeling be the 2003 Citizen's Petitions from Killion and Gudmundsen.