Today, the FDA issued the “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids,” which effectively ends federal enforcement of the hearing aid medical waiver. For those in the dark, the hearing aid medical waiver is a waiver that may be signed in lieu of having the required pre-hearing-aid-purchase medical evaluation. The wording of the original federal regulation (21CFR801.421):
(a) Medical evaluation requirements –(1) General. Except as provided in paragraph (a)(2) of this section, a hearing aid dispenser shall not sell a hearing aid unless the prospective user has presented to the hearing aid dispenser a written statement signed by a licensed physician that states that the patient’s hearing loss has been medically evaluated and the patient may be considered a candidate for a hearing aid. The medical evaluation must have taken place within the preceding 6 months.
(2) Waiver to the medical evaluation requirements. If the prospective hearing aid user is 18 years of age or older, the hearing aid dispenser may afford the prospective user an opportunity to waive the medical evaluation requirement of paragraph (a)(1) …
Medical evaluations will still be required for hearing aid buyers under the age of 18, but adults will be freed from the regulations entirely (no medical evaluation or waiver required). Instead, the FDA has chosen to continue “enforcement of existing labeling requirements for hearing aids including the required notice for prospective hearing aid users.” More specifically, the FDA announcement states that “Hearing aid dispensers are still required to provide all prospective users the opportunity to review the User Instructional Brochure containing specific labeling requirements prior to the sale of a hearing aid device.” The labeling requirements include a list of medical conditions for which a medical evaluation would be advised as well as the following message:
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of the medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.
The FDA announcement does not change any rules regarding over-the-counter (OTC) hearing aids, but does address them. “FDA does intend to consider and address […] recommendations […] regarding a regulatory framework for hearing aids that can be sold directly OTC to consumers, without the requirement for consultation with a credentialed dispenser. FDA intends to solicit additional public input from stakeholders before adopting such an approach.”
Charlie Anderson, the Obama’s Senior Adviser to the Director of the National Economic Council, reflected on the White House blog this morning with following:
In 2015, the President’s Council of Advisors on Science and Technology (PCAST) examined the technology, regulation, and marketplace of hearing aids, leading them to recommend that FDA approve an over-the-counter device. Now—after a two-year study by the National Academies of Sciences, Engineering, and Medicine that also called for an over-the-counter product in alignment with the PCAST recommendation—FDA is announcing it’s ready to take the necessary steps to move forward. Today’s actions are yet another in a series in response to President Obama’s Executive Order promoting competition to benefit consumers, workers, and small businesses.
Charlie Anderson ends his article with the following prediction:
Today’s announcement could start a movement toward over-the-counter hearing aids that will cost a fraction of the $2,300 apiece of current products, helping more of the 30 million Americans who need assistance.
The FDA Commissioner, Robert Califf, M.D., echoed this sentiment in an FDA news release:
“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress […] The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”
We at Hearing Tracker will be paying close attention to this story as it develops, and will continue posting updates as they happen.
Last modified: December 8, 2016